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Publisher: Elsevier   (Total: 3031 journals)

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Showing 1 - 200 of 3031 Journals sorted alphabetically
AASRI Procedia     Open Access   (Followers: 15)
Academic Pediatrics     Hybrid Journal   (Followers: 20, SJR: 1.402, h-index: 51)
Academic Radiology     Hybrid Journal   (Followers: 16, SJR: 1.008, h-index: 75)
Accident Analysis & Prevention     Partially Free   (Followers: 79, SJR: 1.109, h-index: 94)
Accounting Forum     Hybrid Journal   (Followers: 22, SJR: 0.612, h-index: 27)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 27, SJR: 2.515, h-index: 90)
Achievements in the Life Sciences     Open Access   (Followers: 4)
Acta Anaesthesiologica Taiwanica     Open Access   (Followers: 5, SJR: 0.338, h-index: 19)
Acta Astronautica     Hybrid Journal   (Followers: 302, SJR: 0.726, h-index: 43)
Acta Automatica Sinica     Full-text available via subscription   (Followers: 3)
Acta Biomaterialia     Hybrid Journal   (Followers: 25, SJR: 2.02, h-index: 104)
Acta Colombiana de Cuidado Intensivo     Full-text available via subscription  
Acta de Investigación Psicológica     Open Access   (Followers: 2)
Acta Ecologica Sinica     Open Access   (Followers: 8, SJR: 0.172, h-index: 29)
Acta Haematologica Polonica     Free   (SJR: 0.123, h-index: 8)
Acta Histochemica     Hybrid Journal   (Followers: 3, SJR: 0.604, h-index: 38)
Acta Materialia     Hybrid Journal   (Followers: 195, SJR: 3.683, h-index: 202)
Acta Mathematica Scientia     Full-text available via subscription   (Followers: 5, SJR: 0.615, h-index: 21)
Acta Mechanica Solida Sinica     Full-text available via subscription   (Followers: 9, SJR: 0.442, h-index: 21)
Acta Oecologica     Hybrid Journal   (Followers: 9, SJR: 0.915, h-index: 53)
Acta Otorrinolaringologica (English Edition)     Full-text available via subscription   (Followers: 1)
Acta Otorrinolaringológica Española     Full-text available via subscription   (Followers: 3, SJR: 0.311, h-index: 16)
Acta Pharmaceutica Sinica B     Open Access   (Followers: 2)
Acta Poética     Open Access   (Followers: 4)
Acta Psychologica     Hybrid Journal   (Followers: 21, SJR: 1.365, h-index: 73)
Acta Sociológica     Open Access  
Acta Tropica     Hybrid Journal   (Followers: 5, SJR: 1.059, h-index: 77)
Acta Urológica Portuguesa     Open Access  
Actas Dermo-Sifiliograficas     Full-text available via subscription   (Followers: 4)
Actas Dermo-Sifiliográficas (English Edition)     Full-text available via subscription   (Followers: 3)
Actas Urológicas Españolas     Full-text available via subscription   (Followers: 3, SJR: 0.383, h-index: 19)
Actas Urológicas Españolas (English Edition)     Full-text available via subscription   (Followers: 2)
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 5, SJR: 0.141, h-index: 3)
Actualites Pharmaceutiques Hospitalieres     Full-text available via subscription   (Followers: 4, SJR: 0.112, h-index: 2)
Acupuncture and Related Therapies     Hybrid Journal   (Followers: 4)
Ad Hoc Networks     Hybrid Journal   (Followers: 11, SJR: 0.967, h-index: 57)
Addictive Behaviors     Hybrid Journal   (Followers: 15, SJR: 1.514, h-index: 92)
Addictive Behaviors Reports     Open Access   (Followers: 5)
Additive Manufacturing     Hybrid Journal   (Followers: 7, SJR: 1.039, h-index: 5)
Additives for Polymers     Full-text available via subscription   (Followers: 20)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 119, SJR: 5.2, h-index: 222)
Advanced Engineering Informatics     Hybrid Journal   (Followers: 11, SJR: 1.265, h-index: 53)
Advanced Powder Technology     Hybrid Journal   (Followers: 16, SJR: 0.739, h-index: 33)
Advances in Accounting     Hybrid Journal   (Followers: 8, SJR: 0.299, h-index: 15)
Advances in Agronomy     Full-text available via subscription   (Followers: 15, SJR: 2.071, h-index: 82)
Advances in Anesthesia     Full-text available via subscription   (Followers: 24, SJR: 0.169, h-index: 4)
Advances in Antiviral Drug Design     Full-text available via subscription   (Followers: 3)
Advances in Applied Mathematics     Full-text available via subscription   (Followers: 6, SJR: 1.054, h-index: 35)
Advances in Applied Mechanics     Full-text available via subscription   (Followers: 10, SJR: 0.801, h-index: 26)
Advances in Applied Microbiology     Full-text available via subscription   (Followers: 21, SJR: 1.286, h-index: 49)
Advances In Atomic, Molecular, and Optical Physics     Full-text available via subscription   (Followers: 16, SJR: 3.31, h-index: 42)
Advances in Biological Regulation     Hybrid Journal   (Followers: 4, SJR: 2.277, h-index: 43)
Advances in Botanical Research     Full-text available via subscription   (Followers: 3, SJR: 0.619, h-index: 48)
Advances in Cancer Research     Full-text available via subscription   (Followers: 26, SJR: 2.215, h-index: 78)
Advances in Carbohydrate Chemistry and Biochemistry     Full-text available via subscription   (Followers: 9, SJR: 0.9, h-index: 30)
Advances in Catalysis     Full-text available via subscription   (Followers: 5, SJR: 2.139, h-index: 42)
Advances in Cellular and Molecular Biology of Membranes and Organelles     Full-text available via subscription   (Followers: 12)
Advances in Chemical Engineering     Full-text available via subscription   (Followers: 24, SJR: 0.183, h-index: 23)
Advances in Child Development and Behavior     Full-text available via subscription   (Followers: 10, SJR: 0.665, h-index: 29)
Advances in Chronic Kidney Disease     Full-text available via subscription   (Followers: 8, SJR: 1.268, h-index: 45)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 28, SJR: 0.938, h-index: 33)
Advances in Colloid and Interface Science     Full-text available via subscription   (Followers: 18, SJR: 2.314, h-index: 130)
Advances in Computers     Full-text available via subscription   (Followers: 16, SJR: 0.223, h-index: 22)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 11)
Advances in Digestive Medicine     Open Access   (Followers: 4)
Advances in DNA Sequence-Specific Agents     Full-text available via subscription   (Followers: 5)
Advances in Drug Research     Full-text available via subscription   (Followers: 22)
Advances in Ecological Research     Full-text available via subscription   (Followers: 39, SJR: 3.25, h-index: 43)
Advances in Engineering Software     Hybrid Journal   (Followers: 25, SJR: 0.486, h-index: 10)
Advances in Experimental Biology     Full-text available via subscription   (Followers: 7)
Advances in Experimental Social Psychology     Full-text available via subscription   (Followers: 38, SJR: 5.465, h-index: 64)
Advances in Exploration Geophysics     Full-text available via subscription   (Followers: 3)
Advances in Fluorine Science     Full-text available via subscription   (Followers: 8)
Advances in Food and Nutrition Research     Full-text available via subscription   (Followers: 41, SJR: 0.674, h-index: 38)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 14)
Advances in Genetics     Full-text available via subscription   (Followers: 15, SJR: 2.558, h-index: 54)
Advances in Genome Biology     Full-text available via subscription   (Followers: 11)
Advances in Geophysics     Full-text available via subscription   (Followers: 6, SJR: 2.325, h-index: 20)
Advances in Heat Transfer     Full-text available via subscription   (Followers: 18, SJR: 0.906, h-index: 24)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 8, SJR: 0.497, h-index: 31)
Advances in Human Factors/Ergonomics     Full-text available via subscription   (Followers: 22)
Advances in Imaging and Electron Physics     Full-text available via subscription   (Followers: 2, SJR: 0.396, h-index: 27)
Advances in Immunology     Full-text available via subscription   (Followers: 33, SJR: 4.152, h-index: 85)
Advances in Inorganic Chemistry     Full-text available via subscription   (Followers: 9, SJR: 1.132, h-index: 42)
Advances in Insect Physiology     Full-text available via subscription   (Followers: 3, SJR: 1.274, h-index: 27)
Advances in Integrative Medicine     Hybrid Journal   (Followers: 4)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 4)
Advances in Life Course Research     Hybrid Journal   (Followers: 7, SJR: 0.764, h-index: 15)
Advances in Lipobiology     Full-text available via subscription   (Followers: 1)
Advances in Magnetic and Optical Resonance     Full-text available via subscription   (Followers: 8)
Advances in Marine Biology     Full-text available via subscription   (Followers: 16, SJR: 1.645, h-index: 45)
Advances in Mathematics     Full-text available via subscription   (Followers: 10, SJR: 3.261, h-index: 65)
Advances in Medical Sciences     Hybrid Journal   (Followers: 5, SJR: 0.489, h-index: 25)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 5)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 4, SJR: 1.44, h-index: 51)
Advances in Molecular and Cell Biology     Full-text available via subscription   (Followers: 21)
Advances in Molecular and Cellular Endocrinology     Full-text available via subscription   (Followers: 10)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 6, SJR: 0.324, h-index: 8)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 3)
Advances in Oncobiology     Full-text available via subscription   (Followers: 3)
Advances in Organometallic Chemistry     Full-text available via subscription   (Followers: 15, SJR: 2.885, h-index: 45)
Advances in Parallel Computing     Full-text available via subscription   (Followers: 7, SJR: 0.148, h-index: 11)
Advances in Parasitology     Full-text available via subscription   (Followers: 7, SJR: 2.37, h-index: 73)
Advances in Pediatrics     Full-text available via subscription   (Followers: 20, SJR: 0.4, h-index: 28)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 14)
Advances in Pharmacology     Full-text available via subscription   (Followers: 13, SJR: 1.718, h-index: 58)
Advances in Physical Organic Chemistry     Full-text available via subscription   (Followers: 7, SJR: 0.384, h-index: 26)
Advances in Phytomedicine     Full-text available via subscription  
Advances in Planar Lipid Bilayers and Liposomes     Full-text available via subscription   (Followers: 3, SJR: 0.248, h-index: 11)
Advances in Plant Biochemistry and Molecular Biology     Full-text available via subscription   (Followers: 8)
Advances in Plant Pathology     Full-text available via subscription   (Followers: 5)
Advances in Porous Media     Full-text available via subscription   (Followers: 4)
Advances in Protein Chemistry     Full-text available via subscription   (Followers: 18)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 17, SJR: 1.5, h-index: 62)
Advances in Psychology     Full-text available via subscription   (Followers: 56)
Advances in Quantum Chemistry     Full-text available via subscription   (Followers: 5, SJR: 0.478, h-index: 32)
Advances in Radiation Oncology     Open Access  
Advances in Small Animal Medicine and Surgery     Hybrid Journal   (Followers: 1, SJR: 0.1, h-index: 2)
Advances in Space Research     Full-text available via subscription   (Followers: 332, SJR: 0.606, h-index: 65)
Advances in Structural Biology     Full-text available via subscription   (Followers: 7)
Advances in Surgery     Full-text available via subscription   (Followers: 6, SJR: 0.823, h-index: 27)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 28, SJR: 1.321, h-index: 56)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 14)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 12)
Advances in Virus Research     Full-text available via subscription   (Followers: 5, SJR: 1.878, h-index: 68)
Advances in Water Resources     Hybrid Journal   (Followers: 42, SJR: 2.408, h-index: 94)
Aeolian Research     Hybrid Journal   (Followers: 5, SJR: 0.973, h-index: 22)
Aerospace Science and Technology     Hybrid Journal   (Followers: 303, SJR: 0.816, h-index: 49)
AEU - Intl. J. of Electronics and Communications     Hybrid Journal   (Followers: 8, SJR: 0.318, h-index: 36)
African J. of Emergency Medicine     Open Access   (Followers: 4, SJR: 0.344, h-index: 6)
Ageing Research Reviews     Hybrid Journal   (Followers: 7, SJR: 3.289, h-index: 78)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 389, SJR: 1.385, h-index: 72)
Agri Gene     Hybrid Journal  
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 15, SJR: 2.18, h-index: 116)
Agricultural Systems     Hybrid Journal   (Followers: 29, SJR: 1.275, h-index: 74)
Agricultural Water Management     Hybrid Journal   (Followers: 36, SJR: 1.546, h-index: 79)
Agriculture and Agricultural Science Procedia     Open Access  
Agriculture and Natural Resources     Open Access   (Followers: 1)
Agriculture, Ecosystems & Environment     Hybrid Journal   (Followers: 48, SJR: 1.879, h-index: 120)
Ain Shams Engineering J.     Open Access   (Followers: 5, SJR: 0.434, h-index: 14)
Air Medical J.     Hybrid Journal   (Followers: 3, SJR: 0.234, h-index: 18)
AKCE Intl. J. of Graphs and Combinatorics     Open Access   (SJR: 0.285, h-index: 3)
Alcohol     Hybrid Journal   (Followers: 9, SJR: 0.922, h-index: 66)
Alcoholism and Drug Addiction     Open Access   (Followers: 5)
Alergologia Polska : Polish J. of Allergology     Full-text available via subscription   (Followers: 1)
Alexandria Engineering J.     Open Access   (Followers: 1, SJR: 0.436, h-index: 12)
Alexandria J. of Medicine     Open Access  
Algal Research     Partially Free   (Followers: 7, SJR: 2.05, h-index: 20)
Alkaloids: Chemical and Biological Perspectives     Full-text available via subscription   (Followers: 3)
Allergologia et Immunopathologia     Full-text available via subscription   (Followers: 1, SJR: 0.46, h-index: 29)
Allergology Intl.     Open Access   (Followers: 5, SJR: 0.776, h-index: 35)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 6, SJR: 0.158, h-index: 9)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 45, SJR: 4.289, h-index: 64)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 5)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 3)
American Heart J.     Hybrid Journal   (Followers: 45, SJR: 3.157, h-index: 153)
American J. of Cardiology     Hybrid Journal   (Followers: 47, SJR: 2.063, h-index: 186)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 34, SJR: 0.574, h-index: 65)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 6, SJR: 1.091, h-index: 45)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 14, SJR: 1.653, h-index: 93)
American J. of Human Genetics     Hybrid Journal   (Followers: 32, SJR: 8.769, h-index: 256)
American J. of Infection Control     Hybrid Journal   (Followers: 25, SJR: 1.259, h-index: 81)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 31, SJR: 2.313, h-index: 172)
American J. of Medicine     Hybrid Journal   (Followers: 48, SJR: 2.023, h-index: 189)
American J. of Medicine Supplements     Full-text available via subscription   (Followers: 3)
American J. of Obstetrics and Gynecology     Hybrid Journal   (Followers: 173, SJR: 2.255, h-index: 171)
American J. of Ophthalmology     Hybrid Journal   (Followers: 51, SJR: 2.803, h-index: 148)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 2)
American J. of Orthodontics and Dentofacial Orthopedics     Full-text available via subscription   (Followers: 6, SJR: 1.249, h-index: 88)
American J. of Otolaryngology     Hybrid Journal   (Followers: 22, SJR: 0.59, h-index: 45)
American J. of Pathology     Hybrid Journal   (Followers: 23, SJR: 2.653, h-index: 228)
American J. of Preventive Medicine     Hybrid Journal   (Followers: 21, SJR: 2.764, h-index: 154)
American J. of Surgery     Hybrid Journal   (Followers: 32, SJR: 1.286, h-index: 125)
American J. of the Medical Sciences     Hybrid Journal   (Followers: 13, SJR: 0.653, h-index: 70)
Ampersand : An Intl. J. of General and Applied Linguistics     Open Access   (Followers: 5)
Anaerobe     Hybrid Journal   (Followers: 4, SJR: 1.066, h-index: 51)
Anaesthesia & Intensive Care Medicine     Full-text available via subscription   (Followers: 52, SJR: 0.124, h-index: 9)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 3)
Anales de Cirugia Vascular     Full-text available via subscription  
Anales de Pediatría     Full-text available via subscription   (Followers: 2, SJR: 0.209, h-index: 27)
Anales de Pediatría (English Edition)     Full-text available via subscription  
Anales de Pediatría Continuada     Full-text available via subscription   (SJR: 0.104, h-index: 3)
Analytic Methods in Accident Research     Hybrid Journal   (Followers: 2, SJR: 2.577, h-index: 7)
Analytica Chimica Acta     Hybrid Journal   (Followers: 38, SJR: 1.548, h-index: 152)
Analytical Biochemistry     Hybrid Journal   (Followers: 152, SJR: 0.725, h-index: 154)
Analytical Chemistry Research     Open Access   (Followers: 7, SJR: 0.18, h-index: 2)
Analytical Spectroscopy Library     Full-text available via subscription   (Followers: 10)
Anesthésie & Réanimation     Full-text available via subscription  
Anesthesiology Clinics     Full-text available via subscription   (Followers: 21, SJR: 0.421, h-index: 40)
Angiología     Full-text available via subscription   (SJR: 0.124, h-index: 9)
Angiologia e Cirurgia Vascular     Open Access  
Animal Behaviour     Hybrid Journal   (Followers: 141, SJR: 1.907, h-index: 126)
Animal Feed Science and Technology     Hybrid Journal   (Followers: 5, SJR: 1.151, h-index: 83)
Animal Reproduction Science     Hybrid Journal   (Followers: 5, SJR: 0.711, h-index: 78)
Annales d'Endocrinologie     Full-text available via subscription   (SJR: 0.394, h-index: 30)
Annales d'Urologie     Full-text available via subscription  
Annales de Cardiologie et d'Angéiologie     Full-text available via subscription   (SJR: 0.177, h-index: 13)
Annales de Chirurgie de la Main et du Membre Supérieur     Full-text available via subscription  
Annales de Chirurgie Plastique Esthétique     Full-text available via subscription   (Followers: 2, SJR: 0.354, h-index: 22)
Annales de Chirurgie Vasculaire     Full-text available via subscription   (Followers: 1)

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Journal Cover American Heart Journal
  [SJR: 3.157]   [H-I: 153]   [45 followers]  Follow
    
   Hybrid Journal Hybrid journal (It can contain Open Access articles)
   ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
   Published by Elsevier Homepage  [3031 journals]
  • When academic research organizations and clinical research organizations
           disagree: Processes to minimize discrepancies prior to unblinding of
           randomized trials
    • Authors: C. Michael Gibson; Samuel Z. Goldhaber; Alexander T. Cohen; Tarek Nafee; Adrian F. Hernandez; Russell Hull; Serge Korjian; Yazan Daaboul; Gerald Chi; Megan Yee; Robert A. Harrington
      Pages: 1 - 8
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): C. Michael Gibson, Samuel Z. Goldhaber, Alexander T. Cohen, Tarek Nafee, Adrian F. Hernandez, Russell Hull, Serge Korjian, Yazan Daaboul, Gerald Chi, Megan Yee, Robert A. Harrington


      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.018
      Issue No: Vol. 189 (2017)
       
  • Dual antiplatelet therapy in patients with diabetes and acute coronary
           syndromes managed without revascularization
    • Authors: Anthony J. Dalby; Shmuel Gottlieb; Derek D. Cyr; E. Magnus Ohman; Darren K. McGuire; Witold Ruzyllo; Deepak L. Bhatt; Stephen D. Wiviott; Kenneth J. Winters; Keith A.A. Fox; Paul W. Armstrong; Harvey D. White; Dorairaj Prabhakaran; Matthew T. Roe
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Anthony J. Dalby, Shmuel Gottlieb, Derek D. Cyr, Erik Magnus Ohman, Darren K. McGuire, Witold Ruzyllo, Deepak L. Bhatt, Stephen D. Wiviott, Kenneth J. Winters, Keith A.A. Fox, Paul W. Armstrong, Harvey D. White, Dorairaj Prabhakaran, Matthew T. Roe
      Objective Patients with diabetes mellitus (DM) presenting with acute coronary syndrome (ACS) and undergoing percutaneous coronary intervention (PCI) derived enhanced benefit with dual antiplatelet therapy (DAPT) with prasugrel vs. clopidogrel. The risk profile and treatment response to DAPT for medically managed ACS patients with DM remains uncertain. Methods The TRILOGY ACS trial compared aspirin + prasugrel vs. aspirin + clopidogrel for up to 30months in non-ST-segment elevation (NSTE) ACS patients managed medically without revascularization. We compared treatment-related outcomes among 3539 patients with DM vs. 5767 patients without DM. The primary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. Results Patients with vs. without DM were younger, more commonly female, heavier, and more often had revascularization prior to the index ACS event. The frequency of the primary endpoint through 30months was higher among patients with vs. without DM (24.8% vs. 16.3%), with a higher risk for those patients with DM treated with insulin vs. those treated without insulin (35.3% vs. 19.9%). There was no significant difference in the frequency of the primary endpoint by treatment with prasugrel vs. clopiodgrel in those with or without DM (P int =0.82) and with or without insulin treatment among those with DM (P int =0.304). Conclusions Among NSTE ACS patients managed medically without revascularization, patients with DM had a higher risk of ischemic events that was amplified among those treated with insulin. There was no differential treatment effect with a more potent DAPT regimen of aspirin + prasugrel vs. aspirin + clopidogrel.

      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.015
      Issue No: Vol. 188 (2017)
       
  • Feasibility of exercise stress echocardiography and myocardial response in
           patients with repaired congenital heart disease
    • Authors: Babar S. Hasan; Fatima I. Lunze; Najveen Alvi; Keri M. Shafer; Jonathan Rhodes
      Pages: 1 - 10
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Babar S. Hasan, Fatima I. Lunze, Najveen Alvi, Keri M. Shafer, Jonathan Rhodes
      Background Exercise stress echocardiography (ESE) can unmask ventricular dysfunction in asymptomatic patients with congenital heart disease (CHD), but its acquisition and interpretation is often challenging, and the method has not been validated in CHD. This study aimed to evaluate the feasibility of ESE using Doppler imaging and to assess myocardial response to exercise in patients with biventricular (BiV) and univentricular (UniV) circulation after CHD repair. Methods In this single-center prospective study, we recruited 55 participants (17 females), median age 14 years (8-22 years). Our analysis categorized participants in these three groups: with structurally normal hearts as controls (n=21), with BiV circulation (n=20) and with UniV circulation (n=14). We acquired ESE images of the systemic ventricle including pulsed-wave flow and spectral tissue Doppler imaging (TDI) of lateral free wall before and immediately after standard, symptom-limited exercise tests on an electronically braked cycle ergometer. Results During ESE we obtained inflow E-wave and TDI systolic (S′) and early diastolic (E′) velocities in 93% to 100% of participants at rest and in 90% to 100% of participants post exercise. Feasibility to obtain Doppler imaging parameter was the same across study groups. The myocardial response to exercise was increase in heart rate (HR), S′ and inflow E-wave velocity in all participants. Patients with BiV circulation had preserved ventricular function at rest. While patients with UniV circulation had low S′, E′, and E-wave velocities at rest in comparison to controls and to BiV group (all P <.001), both patients with BiV and UniV circulation showed significant increases in HR, S′ velocity and inflow E-wave velocity post exercise, with magnitudes of these increases higher in controls than in the BiV and UniV group. The S′ and E′ velocities were strongly associated with lower percent predicted peak oxygen consumption VO2 (r s =0.614 and r s =0.64, respectively, both P <.001). Conclusion ESE with Doppler imaging is a practical noninvasive diagnostic method and sufficiently robust for the assessment of morphologic LV/systemic ventricles under exercise in patients after biventricular and univentricular CHD repair. Although patients with BiV and UniV circulation had both preserved myocardial response to exercise, the magnitude of this response was the lowest in patients with UniV circulation.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.029
      Issue No: Vol. 188 (2017)
       
  • A prospective, randomized, open-label trial of 6-month versus 12-month
           dual antiplatelet therapy after drug-eluting stent implantation in
           ST-elevation myocardial infarction: Rationale and design of the
           “DAPT-STEMI trial”
    • Authors: Elvin Kedhi; Enrico Fabris; Martin van der Ent; Mark W. Kennedy; Pawel Buszman; Clemens von Birgelen; Stéphane Cook; Hans Wedel; Felix Zijlstra
      Pages: 11 - 17
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Elvin Kedhi, Enrico Fabris, Martin van der Ent, Mark W. Kennedy, Pawel Buszman, Clemens von Birgelen, Stéphane Cook, Hans Wedel, Felix Zijlstra
      Background The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. Hypothesis Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. Study design The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. Summary The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.

      PubDate: 2017-03-23T07:39:56Z
      DOI: 10.1016/j.ahj.2017.02.018
      Issue No: Vol. 188 (2017)
       
  • Relationship between therapeutic effects on infarct size in acute
           myocardial infarction and therapeutic effects on 1-year outcomes: A
           patient-level analysis of randomized clinical trials
    • Authors: Harry P. Selker; James E. Udelson; Robin Ruthazer; Ralph B. D'Agostino; Melissa Nichols; Ori Ben-Yehuda; Ingo Eitel; Christopher B. Granger; Paul Jenkins; Akiko Maehara; Manesh R. Patel; E. Magnus Ohman; Holger Thiele; Gregg W. Stone
      Pages: 18 - 25
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Harry P. Selker, James E. Udelson, Robin Ruthazer, Ralph B. D'Agostino, Melissa Nichols, Ori Ben-Yehuda, Ingo Eitel, Christopher B. Granger, Paul Jenkins, Akiko Maehara, Manesh R. Patel, E. Magnus Ohman, Holger Thiele, Gregg W. Stone
      Background While infarct size in patients with ST-segment elevation myocardial infarction (STEMI) has been generally associated with long-term prognosis, whether a therapeutic effect on infarct size has a corresponding therapeutic effect on long-term outcomes is unknown. Methods Using combined patient-level data from 10 randomized trials of primary percutaneous coronary intervention (PCI) for STEMI, we created multivariable Cox proportional hazard models for one-year heart failure hospitalization and all-cause mortality, which included clinical features and a variable representing treatment effect on infarct size. The trials included 2679 participants; infarct size was measured at a median 4 days post infarction. Results Mean infarct size among the control groups ranged from 16% to 35% of the left ventricle, and from 12% to 36% among treatment groups. There was a significant relationship between treatment effect on infarct size and treatment effect on 1-year heart failure hospitalization (HR 0.85, 95% CI 0.77-0.93, P =.0006), but not on one-year mortality (HR 0.97, 95% CI 0.89-1.06). The treatment effect between infarct size and heart failure hospitalization was stable in sensitivity analyses adjusting for time from STEMI onset to infarct size assessment, and when considering heart failure as the main outcome and death as a competing risk. Conclusions We conclude that early treatment-induced effects on infarct size are related in direction and magnitude to treatment effects on heart failure hospitalizations. This finding enables consideration of using infarct size as a valid surrogate outcome measure in assessing new STEMI treatments.

      PubDate: 2017-03-23T07:39:56Z
      DOI: 10.1016/j.ahj.2017.02.028
      Issue No: Vol. 188 (2017)
       
  • Digital health intervention during cardiac rehabilitation: A randomized
           controlled trial
    • Authors: R. Jay Widmer; Thomas G. Allison; Ryan Lennon; Francisco Lopez-Jimenez; Lilach O. Lerman; Amir Lerman
      Pages: 65 - 72
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): R. Jay Widmer, Thomas G. Allison, Ryan Lennon, Francisco Lopez-Jimenez, Lilach O. Lerman, Amir Lerman
      Background Digital health interventions (DHI) have been shown to improve intermediates of cardiovascular health, but their impact on cardiovascular (CV) outcomes has not been fully explored. The aim of this study was to determine whether DHI administered during cardiac rehabilitation (CR) would reduce CV-related emergency department (ED) visits and rehospitalizations in patients after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Methods We randomized patients undergoing CR following ACS and PCI to standard CR (n=40) or CR+DHI (n=40) for 3 months with 3 patients withdrawing from CR prior to initiation in the treatment arm and 6 in the control group. The DHI incorporated an online and smartphone-based CR platform asking the patients to report of dietary and exercise habits throughout CR as well as educational information toward patients' healthy lifestyles. We obtained data regarding ED visits and rehospitalizations at 180 days, as well as other metrics of secondary CV prevention at baseline and 90 days. Results Baseline demographics were similar between the groups. The DHI+CR group had improved weight loss compared to the control group (−5.1±6.5 kg vs. −0.8±3.8 kg, respectively, P =.02). Those in the DHI+CR group also showed a non-significant reduction in CV-related rehospitalizations plus ED visits compared to the control group at 180 days (8.1% vs 26.6%; RR 0.30, 95% CI 0.08-1.10, P =.054). Conclusions The current study demonstrated that complementary DHI significantly improves weight loss, and might offer a method to reduce CV-related ED visits plus rehospitalizations in patients after ACS undergoing CR. The study suggests a role for DHI as an adjunct to CR to improve secondary prevention of CV disease. Trial registration This trial is registered at clinicaltrials.gov (NCT01883050).

      PubDate: 2017-03-30T07:53:13Z
      DOI: 10.1016/j.ahj.2017.02.016
      Issue No: Vol. 188 (2017)
       
  • Use of prasugrel vs clopidogrel and outcomes in patients with acute
           coronary syndrome undergoing percutaneous coronary intervention in
           contemporary clinical practice: Results from the PROMETHEUS study
    • Authors: Usman Baber; Samantha Sartori; Melissa Aquino; Annapoorna Kini; Samir Kapadia; Sandra Weiss; Craig Strauss; J. Brent Muhlestein; Catalin Toma; Sunil V. Rao; Anthony DeFranco; Kanhaiya L. Poddar; Jaya Chandrasekhar; William Weintraub; Timothy D. Henry; Sameer Bansilal; Brian A. Baker; Elizabeth Marrett; Stuart Keller; Mark Effron; Stuart Pocock; Roxana Mehran
      Pages: 73 - 81
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Usman Baber, Samantha Sartori, Melissa Aquino, Annapoorna Kini, Samir Kapadia, Sandra Weiss, Craig Strauss, J. Brent Muhlestein, Catalin Toma, Sunil V. Rao, Anthony DeFranco, Kanhaiya L. Poddar, Jaya Chandrasekhar, William Weintraub, Timothy D. Henry, Sameer Bansilal, Brian A. Baker, Elizabeth Marrett, Stuart Keller, Mark Effron, Stuart Pocock, Roxana Mehran
      Background and objectives We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. Methods PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. Results Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P <.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P <.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. Conclusions In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.02.013
      Issue No: Vol. 188 (2017)
       
  • Electronically self-assessed functional capacity and exercise testing: A
           comparison of the Duke Activity Status Index and Patient-Reported Outcomes
           Measurement Information System tools
    • Authors: Ryan A. Coute; Jesse M. Ehrenfeld; Deepak K. Gupta; Maxim A. Terekhov; Jonathan P. Wanderer
      Pages: 82 - 86
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Ryan A. Coute, Jesse M. Ehrenfeld, Deepak K. Gupta, Maxim A. Terekhov, Jonathan P. Wanderer
      Purpose Electronic screening tools, such as Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short-Form 12a (PF-SF12a), may aid in the assessment of functional capacity. However, PROMIS PF-SF12a has not been validated against exercise capacity, or compared with established questionnaires, including the Duke Activity Status Index (DASI). We compared the DASI and PROMIS PF-SF12a to the maximum metabolic equivalents (METs) achieved during exercise stress testing. Methods DASI and PROMIS PF-SF12a were electronically administered to 100 adult patients (median age 56years, 61% male) immediately before exercise stress testing. DASI-predicted METs and PROMIS T score were calculated. Correlations with exercise METs with and without age adjustment were examined. Linear regression lines were derived and adjusted r 2 statistic was calculated. We compared models with the Davidson-Mackinnon J test. Results The median (interquartile range) DASI-predicted METs, PROMIS Tscore, and exercise METs were 8.97 (7.61-9.89), 47.90 (43.33-52.40), and 10.10 (10.10-12.80), respectively. In unadjusted correlation analyses, PROMIS accounted for 26% of the variance in exercise METs compared with 38% with DASI. With age adjustment, the r 2values increased to 0.36 (PROMIS) and 0.46 (DASI). In both unadjusted and age-adjusted analyses, inclusion of DASI improved prediction of exercise METs beyond PROMIS T score (P <.0001). In contrast, PROMIS T score did not improve exercise MET prediction compared with DASI alone (P >.10). Conclusion Among patients undergoing clinically indicated exercise stress testing, DASI outperformed PROMIS PF-SF12a as a predictor of exercise METs.

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.03.005
      Issue No: Vol. 188 (2017)
       
  • Atrial fibrillation incrementally increases dementia risk across all
           CHADS2 and CHA2DS2VASc strata in patients receiving long-term warfarin
    • Authors: Kevin G. Graves; Heidi T. May; Victoria Jacobs; Tami L. Bair; Scott M. Stevens; Scott C. Woller; Brian G. Crandall; Michael J. Cutler; John D. Day; Charles Mallender; Jeffrey S. Osborn; J. Peter Weiss; T. Jared Bunch
      Pages: 93 - 98
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Kevin G. Graves, Heidi T. May, Victoria Jacobs, Tami L. Bair, Scott M. Stevens, Scott C. Woller, Brian G. Crandall, Michael J. Cutler, John D. Day, Charles Mallender, Jeffrey S. Osborn, J. Peter Weiss, T. Jared Bunch
      Background Patients with atrial fibrillation (AF) are at higher risk for developing dementia. Warfarin is a common therapy for the prevention of thromboembolism in AF, valve replacement, and thrombosis patients. The extent to which AF itself increases dementia risk remains unknown. Methods A total 6030 patients with no history of dementia and chronically anticoagulated with warfarin were studied. Warfarin management was provided through a Clinical Pharmacy Anticoagulation Service. Patients were stratified by warfarin indication of AF (n=3015) and non-AF (n=3015) and matched by propensity score (±0.01). Patients were stratified by the congestive heart failure, hypertension, age >75 years, diabetes, stroke (CHADS2) score calculated at the time of warfarin initiation and followed for incident dementia. Results The average age of the AF cohort was 69.3±11.2 years, and 52.7% were male; average age of non-AF cohort was 69.3±10.9 years, and 51.5% were male. Increasing CHADS2 score was associated with increased dementia incidence, P trend=.004. When stratified by warfarin indication, AF patients had an increased risk of dementia incidence. After multivariable adjustment, AF patients continued to display a significantly increased risk of dementia when compared with non-AF patients across all CHADS2 scores strata. Conclusions In patients receiving long-term warfarin therapy, dementia risk increased with increasing CHADS2 scores. However, the presence of AF was associated with higher rates of dementia across all CHADS2 score strata. These data suggest that AF contributes to the risk of dementia and that this risk is not solely attributable to anticoagulant use. Dementia may be an end manifestation of a systemic disease state, and AF likely contributes to its progression.
      Graphical abstract image

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.02.026
      Issue No: Vol. 188 (2017)
       
  • Rationale, design, and baseline characteristics of the Salt Substitute and
           Stroke Study (SSaSS)—A large-scale cluster randomized controlled trial
    • Authors: Bruce Neal; Maoyi Tian; Nicole Li; Paul Elliott; Lijing L. Yan; Darwin R. Labarthe; Liping Huang; Xuejun Yin; Zhixin Hao; Sandrine Stepien; Jingpu Shi; Xiangxian Feng; Jianxin Zhang; Yuhong Zhang; Ruijuan Zhang; Yangfeng Wu
      Pages: 109 - 117
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Bruce Neal, Maoyi Tian, Nicole Li, Paul Elliott, Lijing L. Yan, Darwin R. Labarthe, Liping Huang, Xuejun Yin, Zhixin Hao, Sandrine Stepien, Jingpu Shi, Xiangxian Feng, Jianxin Zhang, Yuhong Zhang, Ruijuan Zhang, Yangfeng Wu
      Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data.

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.02.033
      Issue No: Vol. 188 (2017)
       
  • Clinical SYNTAX score predicts outcomes of patients undergoing coronary
           artery bypass grafting
    • Authors: Giovanni Melina; Emiliano Angeloni; Simone Refice; Francesco Monti; Roberto Serdoz; Stefano Rosato; Fulvia Seccareccia; Furio Colivicchi; Roberta Serdoz; Francesco Paneni; Riccardo Sinatra
      Pages: 118 - 126
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Giovanni Melina, Emiliano Angeloni, Simone Refice, Francesco Monti, Roberto Serdoz, Stefano Rosato, Fulvia Seccareccia, Furio Colivicchi, Roberta Serdoz, Francesco Paneni, Riccardo Sinatra
      Background The SYNTAX score (SS) is a determinant of outcome in patients undergoing percutaneous coronary intervention. In addition, it has been recently shown that the clinical SYNTAX score (cSS), obtained by adding clinical variables to the SS, improves the predictive power of the resulting risk model. We assessed the hypothesis that the use of the cSS may predict outcomes of patients undergoing coronary artery bypass grafting (CABG). Methods We measured the SYNTAX score in 874 patients undergoing isolated first time on-pump CABG. The clinical SYNTAX score was calculated at the time of the study using age, creatinine clearance and ejection fraction, the modified ACEF score, and analyses performed for major adverse cardiac and cerebrovascular events (MACCE) and all-cause mortality at 3-year follow-up. Results The mean age of the study population was 70.9 ± 8.1 years, and the median cSS 14.2 (range 2.1–286.5). The ROC curve analysis showed that a cSS >14.5 (81.4% sensitivity and 67.8% specificity) was a reliable tool in discrimination of patients for the occurrence of MACCE (AUC 0.78) and all-cause mortality (AUC 0.74). Kaplan-Meier survival analysis confirmed that patients belonging to higher cSS quartiles have poorer 3-year survival (P = .0001) and MACCE-free survival (P = .0001), with respect to those with lower cSS. Conclusions This observational study has shown that the clinical SYNTAX score, incorporating the lesion-based SS and clinical-based ACEF score, predicted mid-term adverse outcomes of patients undergoing CABG and may play an important role in the risk stratification of this population. Further studies are needed to confirm these findings.

      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.016
      Issue No: Vol. 188 (2017)
       
  • Characterization of hemodynamically stable acute heart failure patients
           requiring a critical care unit admission: Derivation, validation, and
           refinement of a risk score
    • Authors: Ismail R. Raslan; Paul Brown; Cynthia M. Westerhout; Justin A. Ezekowitz; Adrian F. Hernandez; Randall C. Starling; Christopher O'Connor; Finlay A. McAlister; Brian H. Rowe; Paul W. Armstrong; Sean van Diepen
      Pages: 127 - 135
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Ismail R. Raslan, Paul Brown, Cynthia M. Westerhout, Justin A. Ezekowitz, Adrian F. Hernandez, Randall C. Starling, Christopher O'Connor, Finlay A. McAlister, Brian H. Rowe, Paul W. Armstrong, Sean van Diepen
      Background Most patients with acute heart failure (AHF) admitted to critical care units (CCUs) are low acuity and do not require CCU-specific therapies, suggesting that they could be managed in a lower-cost ward environment. This study identified the predictors of clinical events and the need for CCU-specific therapies in patients with AHF. Methods Model derivation was performed using data from patients in the ASCEND-HF trial cohort (n=7,141), and the Acute Heart Failure Emergency Management community-based registry (n=666) was used to externally validate the model and to test the incremental prognostic utility of 4 variables (heart failure etiology, troponin, B-type natriuretic peptide [BNP], ejection fraction) using net reclassification index and integrated discrimination improvement. The primary outcome was an in-hospital composite of the requirement for CCU-specific therapies or clinical events. Results The primary composite outcome occurred in 545 (11.4%) derivation cohort participants (n=4,767) and 7 variables were predictors of the primary composite outcome: body mass index, chronic respiratory disease, respiratory rate, resting dyspnea, hemoglobin, sodium, and blood urea nitrogen (c index=0.633, Hosmer-Lemeshow P =.823). In the validation cohort (n=666), 87 (13.1%) events occurred (c index=0.629, Hosmer-Lemeshow P =.386) and adding ischemic heart failure, troponin, and B-type natriuretic peptide improved model performance (net reclassification index 0.79, 95% CI 0.046-0.512; integrated discrimination improvement 0.014, 95% CI 0.005-0.0238). The final 10-variable clinical prediction model demonstrated modest discrimination (c index=0.702) and good calibration (Hosmer-Lemeshow P =.547). Conclusions We derived, validated, and improved upon a clinical prediction model in an international trial and a community-based cohort of AHF. The model has modest discrimination; however, these findings deserve further exploration because they may provide a more accurate means of triaging level of care for patients with AHF who need admission.

      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.014
      Issue No: Vol. 188 (2017)
       
  • Diastolic dysfunction revisited: A new, feasible, and unambiguous
           echocardiographic classification predicts major cardiovascular events
    • Authors: Niklas Dyrby Johansen; Tor Biering-Sørensen; Jan Skov Jensen; Rasmus Mogelvang
      Pages: 136 - 146
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Niklas Dyrby Johansen, Tor Biering-Sørensen, Jan Skov Jensen, Rasmus Mogelvang
      Background Echocardiographic classification of DDF has been widely discussed. The aim of this study was to investigate the independent prognostic value of established echocardiographic measures in a community-based population and create a new classification of DDF. Methods Within the Copenhagen City Heart Study, a prospective, community-based study, 1851 participants were examined by echocardiography including Tissue Doppler Imaging (TDI) in 2001 to 2003 and followed with regard to MACE (median, 10.9 years). Results We found that persons with impaired myocardial relaxation as defined by low peak early diastolic mitral annular velocity e' by TDI had higher incidence of clinical and echocardiographic markers of cardiac dysfunction and increased risk of MACE. Among persons with impaired relaxation, only echocardiographic indices of increased filling pressures such as LAVi ≥34 mL/m2 (HR 1.97 (1.13-3.45, P =.017), E/e′ ≥ 17 (HR 1.89 (1.34-2.65), P <.001), and E/A >2 (HR 5.24 (1.91-14.42), P =.001) provided additional and independent prognostic information on MACE. Based on these findings, we created a new classification of DDF where all grades were significant predictors of MACE independently of age, sex, and cardiac clinical risk markers (Mild DDF: HR 1.99 (1.23-3.21), P =.005; Moderate DDF: HR 3.11 (1.81-5.34), P <.001; Severe DDF: HR 4.20 (1.81-9.73), P <.001). Increasing severity of DDF was linearly associated with increasing plasma proBNP concentrations. Conclusions In the general population, the presence of echocardiographic markers of elevated filling pressures in persons with impaired relaxation increased the risk of MACE significantly. Based on this, we present a new, feasible, and unambiguous classification of DDF capable of accurate risk prediction in the community.

      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.013
      Issue No: Vol. 188 (2017)
       
  • Cangrelor reduces the risk of ischemic complications in patients with
           single-vessel and multi-vessel disease undergoing percutaneous coronary
           intervention: Insights from the CHAMPION PHOENIX trial
    • Authors: Freddy Abnousi; Vandana Sundaram; Celina M. Yong; Jayne Prats; Efthymios N. Deliargyris; Gregg W. Stone; Christian W. Hamm; Philippe Gabriel Steg; Charles Michael Gibson; Harvey D. White; Matthew J. Price; Philippe Généreux; Manisha Desai; Lingyao Yang; Victoria Y. Ding; Robert A. Harrington; Deepak L. Bhatt; Kenneth W. Mahaffey
      Pages: 147 - 155
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Freddy Abnousi, Vandana Sundaram, Celina M. Yong, Jayne Prats, Efthymios N. Deliargyris, Gregg W. Stone, Christian W. Hamm, Philippe Gabriel Steg, Charles Michael Gibson, Harvey D. White, Matthew J. Price, Philippe Généreux, Manisha Desai, Lingyao Yang, Victoria Y. Ding, Robert A. Harrington, Deepak L. Bhatt, Kenneth W. Mahaffey
      Objective To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). Background Cangrelor, an intravenous, rapidly acting P2Y12 inhibitor, is superior to clopidogrel in reducing ischemic events among patients receiving percutaneous coronary intervention (PCI). Methods We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non–coronary artery bypass grafting GUSTO severe bleeding at 48hours. Results Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P =.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. Conclusion In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. Clinical perspectives What's known? Cangrelor is a novel, intravenous, potent, and rapidly acting P2Y12 inhibitor that has been demonstrated to reduce the rate of ischemic events at 48hours in patients who received PCI compared with clopidogrel. What's new? In contrast to prior studies, we found that in this modern cohort, patients with SVD and MVD had a similar risk of ischemic complications and GUSTO severe bleeding after PCI. We also found that cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. What's next? To assess the impact of single vessel PCI versus multivessel PCI in patients with SVD and MVD.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.02.031
      Issue No: Vol. 188 (2017)
       
  • A randomized double-blind trial of an interventional device treatment of
           functional mitral regurgitation in patients with symptomatic congestive
           heart failure—Trial design of the REDUCE FMR study
    • Authors: Steven L. Goldberg; Ian Meredith; Thomas Marwick; Brian A. Haluska; Janusz Lipiecki; Tomasz Siminiak; Nawzer Mehta; David M. Kaye; Horst Sievert
      Pages: 167 - 174
      Abstract: Publication date: June 2017
      Source:American Heart Journal, Volume 188
      Author(s): Steven L. Goldberg, Ian Meredith, Thomas Marwick, Brian A. Haluska, Janusz Lipiecki, Tomasz Siminiak, Nawzer Mehta, David M. Kaye, Horst Sievert
      The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus–based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.02.032
      Issue No: Vol. 188 (2017)
       
  • Association of measured platelet reactivity with changes in P2Y12 receptor
           inhibitor therapy and outcomes after myocardial infarction: Insights into
           routine clinical practice from the TReatment with ADP receptor iNhibitorS:
           Longitudinal Assessment of Treatment Patterns and Events after Acute
           Coronary Syndrome (TRANSLATE-ACS) study
    • Authors: Akshay Bagai; Eric D. Peterson; Lisa A. McCoy; Mark B. Effron; Marjorie E. Zettler; Gregg W. Stone; Timothy D. Henry; David J. Cohen; Phillip J. Schulte; Kevin J. Anstrom; Tracy Y. Wang
      Pages: 19 - 28
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Akshay Bagai, Eric D. Peterson, Lisa A. McCoy, Mark B. Effron, Marjorie E. Zettler, Gregg W. Stone, Timothy D. Henry, David J. Cohen, Phillip J. Schulte, Kevin J. Anstrom, Tracy Y. Wang
      Background Little is known about the use of platelet function testing to guide choice of P2Y12 receptor inhibitor therapy in routine clinical practice. Methods We studied 671 myocardial infarction (MI) patients treated with percutaneous coronary intervention in the TRANSLATE-ACS Registry who had VerifyNow platelet function testing performed while on clopidogrel treatment during their index hospitalization (April 2010–October 2012). Results High platelet reactivity (>208 platelet reactivity units [PRU]) was present in 261 (38.9%) patients. Clopidogrel was switched in-hospital to prasugrel in 80 (30.7%) patients with high platelet reactivity and 18 (4.4%) patients with therapeutic platelet reactivity (≤208 PRU). Among high platelet reactivity patients, switch to prasugrel was associated with lower major adverse cardiovascular events (death, MI, stroke, or unplanned revascularization) at 1year (10.0% vs 22.7%, P =.02; adjusted odds ratio [OR] 0.39, 95% CI 0.18-0.85, P =.02) and no significant difference in Bleeding Academic Research Consortium type 2 or higher bleeding (23.8% vs 22.1%, P =.77; adjusted OR 0.91, 95% CI 0.48-1.7, P =.77) compared with patients continued on clopidogrel. No significant differences in major adverse cardiovascular event (22.2% vs 12.8%, P =.25; adjusted OR 1.8, 95% CI 0.47-7.3, P =.38) or bleeding (22.2% vs 19.4%, P =.77; adjusted OR 1.3, 95% CI 0.27-6.8, P =.72) were observed among therapeutic platelet reactivity patients between switching and continuation on clopidogrel. Conclusions Only one-third of percutaneous coronary intervention–treated MI patients with high on-clopidogrel platelet reactivity were switched to a more potent P2Y12 receptor inhibitor. Intensification of antiplatelet therapy was associated with lower risk of ischemic events at 1year among HPR patients.

      PubDate: 2017-03-06T10:38:32Z
      DOI: 10.1016/j.ahj.2017.02.003
      Issue No: Vol. 187 (2017)
       
  • Managing subfertility in patients with heart disease: What are the
           choices'
    • Authors: Matthew Cauldwell; Roshni R Patel; Philip J Steer; Lorna Swan; Julian Norman-Taylor; Michael Gatzoulis; Mark R Johnson
      Pages: 29 - 36
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Matthew Cauldwell, Roshni R Patel, Philip J Steer, Lorna Swan, Julian Norman-Taylor, Michael Gatzoulis, Mark R Johnson
      More women with heart disease are reaching reproductive age and will want to embark upon pregnancy. Furthermore, many of these women are delaying pregnancy until later in life when they may be exposed to a greater number of complications from their heart disease. A relatively high proportion of these women will pursue fertility treatment to achieve a pregnancy; consequently, the management of subfertile couples where the woman (or man) has heart disease is of growing importance. In this review, we discuss how fertility investigations and treatment can impact a women with heart disease and how some of the potential complications can be minimized or avoided. We also consider surrogacy, which is an important option when pregnancy is contraindicated.

      PubDate: 2017-03-06T10:38:32Z
      DOI: 10.1016/j.ahj.2017.02.007
      Issue No: Vol. 187 (2017)
       
  • Assessing MICRO-vascular resistances via IMR to predict outcome in STEMI
           patients with multivessel disease undergoing primary PCI (AMICRO):
           Rationale and design of a prospective multicenter clinical trial
    • Authors: Massimo Fineschi; Edoardo Verna; Giuseppe Mezzapelle; Davide Bartolini; Giovanni Turiano; Antonio Manari; Katia Lucarelli; Lucia Uguccioni; Alessandra Repetto; Giuseppe Tarantini
      Pages: 37 - 44
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Massimo Fineschi, Edoardo Verna, Giuseppe Mezzapelle, Davide Bartolini, Giovanni Turiano, Antonio Manari, Katia Lucarelli, Lucia Uguccioni, Alessandra Repetto, Giuseppe Tarantini
      Background In STEMI patients treated with primary percutaneous coronary angioplasty (PPCI) the evaluation of coronary microcirculatory resistance index (IMR) predict the extent of microvascular damage and left ventricular (LV) remodeling. However, the impact of IMR on the clinical outcome after PPCI in patients with multivessel disease (MVD) remains unsettled. Aim We designed a prospective multicenter controlled clinical trial to evaluate the prognostic value of IMR in terms of clinical outcome and left ventricular remodeling in STEMI patients with MVD undergoing PPCI. Methods and design The study will involve 242 patients with MVD defines as the presence of at least a non-culprit lesion of >50% stenosis at index coronary angiography. Both fractional flow reserve (FFR) and IMR will be measured in the infarct-related artery (IRA) after successful PPCI. Measurements of FFR and IMR will be repeated in the IRA and performed in the non-culprit vessels at staged angiography. The non-culprit vessel lesions will be treated only in the presence of a FFR<0.75. A 2D echocardiographic evaluation of the left ventricular (LV) volumes and ejection fraction will be performed before hospital discharge and at 1-year follow-up. The primary end-point of the study will be the composite of cardiovascular death, re-hospitalization for heart failure and resuscitation or appropriate ICD shock during 1-year of follow-up. Secondary end-points will be the impact of IMR in predicting LV remodeling during follow-up and correlations between IMR and ST-segment resolution. Other secondary endpoints will be need for new revascularization, stent thrombosis and re-infarction of the non-culprit vessels territory. Implications If IMR significantly correlates with differences in outcome and LV remodeling, it will emerge as a potential prognostic index after PPCI in patients with MVD.

      PubDate: 2017-03-11T11:01:17Z
      DOI: 10.1016/j.ahj.2017.02.019
      Issue No: Vol. 187 (2017)
       
  • Clinical decision support for stroke prevention in atrial fibrillation
           (CDS-AF): Rationale and design of a cluster randomized trial in the
           primary care setting
    • Authors: Lars O. Karlsson; Staffan Nilsson; Emmanouil Charitakis; Magnus Bång; Gustav Johansson; Lennart Nilsson; Magnus Janzon
      Pages: 45 - 52
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Lars O. Karlsson, Staffan Nilsson, Emmanouil Charitakis, Magnus Bång, Gustav Johansson, Lennart Nilsson, Magnus Janzon
      Background Atrial fibrillation (AF) is associated with substantial morbidity, in particular stroke. Despite good evidence for the reduction of stroke risk with anticoagulant therapy, there remains a significant undertreatment. The main aim of the current study is to investigate whether a clinical decision support tool for stroke prevention (CDS) integrated in the electronic health record can improve adherence to guidelines for stroke prevention in patients with AF. Methods We will conduct a cluster randomized trial where 43 primary care clinics in the county of Östergötland, Sweden (population 444,347), will be randomized to be part of the CDS intervention or serve as controls. The CDS will alert responsible physicians of patients with AF and increased risk for thromboembolism according to the CHA2DS2VASc (Congestive heart failure, Hypertension, Age ≥ 74 years, Diabetes mellitus, previous Stroke/TIA/thromboembolism, Vascular disease, Age 65-74 years, Sex category (i.e. female sex)) algorithm without anticoagulant therapy. The primary end point will be adherence to guidelines after 1 year. Conclusion The present study will investigate whether a clinical decision support system integrated in an electronic health record can increase adherence to guidelines regarding anticoagulant therapy in patients with AF.

      PubDate: 2017-03-11T11:01:17Z
      DOI: 10.1016/j.ahj.2017.02.009
      Issue No: Vol. 187 (2017)
       
  • An examination of the relationship between serum uric acid level, a
           clinical history of gout, and cardiovascular outcomes among patients with
           acute coronary syndrome
    • Authors: Neha J. Pagidipati; Connie N. Hess; Robert M. Clare; Axel Akerblom; Pierluigi Tricoci; Daniel Wojdyla; Robert T. Keenan; Stefan James; Claes Held; Kenneth W. Mahaffey; Alyssa B. Klein; Lars Wallentin; Matthew T. Roe
      Pages: 53 - 61
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Neha J. Pagidipati, Connie N. Hess, Robert M. Clare, Axel Akerblom, Pierluigi Tricoci, Daniel Wojdyla, Robert T. Keenan, Stefan James, Claes Held, Kenneth W. Mahaffey, Alyssa B. Klein, Lars Wallentin, Matthew T. Roe
      Background Studies have suggested a relationship between higher baseline serum uric acid (sUA) levels and an elevated risk of subsequent ischemic cardiovascular outcomes among acute coronary syndrome (ACS) patients; this relationship may be modified by a clinical history of gout and has not been studied in large patient cohorts. We sought to understand the effect of sUA and gout on ACS outcomes. Methods Using PLATO and TRACER data on 27,959 ACS patients, we evaluated baseline sUA levels in relation to a composite of cardiovascular death, myocardial infarction (MI), or stroke. We assessed interaction terms to determine if a baseline clinical diagnosis of gout modified this putative relationship; 46% (n=12,882) had sUA levels elevated >6.0 mg/dL. Results Patients with elevated levels were more often male with a history of prior MI, diabetes, and heart failure compared with those with sUA <6.0 mg/dL. The unadjusted risk of the composite endpoint increased with corresponding elevations in sUA levels (per 1 mg/dL increase) (HR=1.23 [95% CI: 1.20–1.26]) above the statistical inflection point of 5.0 mg/dL. After adjustment, the association between sUA level and the composite outcome remained significant (HR=1.07 [95% CI: 1.04–1.10]), and baseline gout did not modify this relationship. Conclusions In patients with ACS, increasing levels of sUA are associated with an elevated risk of cardiovascular events, regardless of a clinical diagnosis of gout. Further investigation is warranted to determine the mechanism behind this relationship and to delineate whether sUA is an appropriate therapeutic target to reduce cardiovascular risk.

      PubDate: 2017-03-11T11:01:17Z
      DOI: 10.1016/j.ahj.2017.02.023
      Issue No: Vol. 187 (2017)
       
  • Time to achieving therapeutic international normalized ratio increases
           hospital length of stay after heart valve replacement surgery
    • Authors: Christopher J. Arendt; Joon Hwa Hong; Richard C. Daly; Christopher Scott; Ramila A. Mehta; Kent Bailey; Jyotishman Pathak; Naveen L. Pereira
      Pages: 70 - 77
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Christopher J. Arendt, Joon Hwa Hong, Richard C. Daly, Christopher Scott, Ramila A. Mehta, Kent Bailey, Jyotishman Pathak, Naveen L. Pereira
      Background Achieving a therapeutic international normalized ratio (INR) before hospital discharge is an important inpatient goal for patients undergoing mechanical cardiac valve replacement (MCVR). The use of clinical algorithms has reduced the time to achieve therapeutic INR (TTI) with warfarin therapy. Whether TTI prolongs length of stay (LOS) is unknown. Methods Patients who underwent MCVR over a consecutive 42-month period were included. Clinical data were obtained from the Society of Thoracic Surgeons Adult Cardiac Surgery database and electronic medical records. Therapeutic INR was defined as per standard guidelines. Warfarin dose was prescribed using an inpatient pharmacy-managed algorithm and computer-based dosing tool. International normalized ratio trajectory, procedural needs, and drug interactions were included in warfarin dose determination. Results There were 708 patients who underwent MCVR, of which 159 were excluded for reasons that would preclude or interrupt warfarin use. Among the remainder of 549 patients, the average LOS was 6.4days and mean TTI was 3.5days. Landmark analysis showed that subjects in hospital on day 4 (n=542) who achieved therapeutic INR were more likely to be discharged by day 6 compared with those who did not achieve therapeutic INR (75% vs 59%, P <.001). Multivariable proportional hazards regression with TTI as a time-dependent effect showed a strong association with discharge (P =.0096, hazard ratio1.3) after adjustment for other significant clinical covariates. Conclusions Time to achieve therapeutic INR is an independent predictor of LOS in patients requiring anticoagulation with warfarin after MCVR surgery. Alternative dosing and anticoagulation strategies will need to be adopted to reduce LOS in these patients.

      PubDate: 2017-03-11T11:01:17Z
      DOI: 10.1016/j.ahj.2017.02.011
      Issue No: Vol. 187 (2017)
       
  • Factors associated with rhythm control treatment decisions in patients
           with atrial fibrillation—Insights from the NCDR PINNACLE registry
    • Authors: Anil K. Gehi; Gheorghe Doros; Thomas J. Glorioso; Gary K. Grunwald; Jonathan Hsu; Yang Song; Mintu P. Turakhia; Alexander Turchin; Salim S. Virani; Thomas M. Maddox
      Pages: 88 - 97
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Anil K. Gehi, Gheorghe Doros, Thomas J. Glorioso, Gary K. Grunwald, Jonathan Hsu, Yang Song, Mintu P. Turakhia, Alexander Turchin, Salim S. Virani, Thomas M. Maddox
      Background Decisions to use rhythm control in atrial fibrillation (AF) should generally be dictated by patient factors, such as quality of life, heart failure, and other comorbidities. Whether or not other factors affect decisions about the use of rhythm control, and catheter ablation in particular, is unknown. Methods A cohort of all patients diagnosed with nonvalvular AF were identified from the National Cardiovascular Data Registry’s Practice Innovation and Clinical Excellence (PINNACLE) AF registry of US outpatient cardiology practices during the study period from May 1, 2008, to December 31, 2014. Overall and practice-specific rates of rhythm control (cardioversion, antiarrhythmic drug therapy, or catheter ablation) were assessed. We assessed patient and practice factors associated with rhythm control and determined the relative contribution of patient, practice, and unmeasured practice factors with its use. Results Among 511,958 PINNACLE AF patients, 22.3% were treated with rhythm control and 2.9% underwent catheter ablation. Significant practice variation in rhythm control was present (median rate of rhythm control across practices 22.8%, range 0.2%-62.9%). Significant patient factors associated with rhythm control therapy included white (vs nonwhite) race (odds ratio [OR] 2.43, P <.001), private (vs nonprivate) insurance (OR 1.04, P <.001), and whether a patient was seen by an electrophysiologist (OR 1.77, P <.001). In an analysis of the relative contribution of patient, practice, and unmeasured practice factors with rhythm control, the contribution of unmeasured practice factors (95% range OR 0.29-3.44) exceeded that of either patient (95% range OR 0.46-2.30) or practice (95% range OR 0.15-2.77) factors. Conclusions One in 5 AF patients in the PINNACLE registry received rhythm control, and 1 in 50 received catheter ablation, suggesting that rhythm control may be underused. A variety of measured and unmeasured practice factors unrelated to patient characteristics play a disproportionate role in the use of rhythm control treatment decisions. Understanding the drivers of these decisions may identify inappropriate treatment variation and better inform optimal use of these therapies.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.006
      Issue No: Vol. 187 (2017)
       
  • Percutaneous revascularization in patients treated with thoracic radiation
           for cancer
    • Authors: Erin A. Fender; Jackson J. Liang; Terence T. Sio; John M. Stulak; Ryan J. Lennon; Joshua P. Slusser; Jonathan B. Ashman; Robert C. Miller; Joerg Herrmann; Abhiram Prasad; Gurpreet S. Sandhu
      Pages: 98 - 103
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Erin A. Fender, Jackson J. Liang, Terence T. Sio, John M. Stulak, Ryan J. Lennon, Joshua P. Slusser, Jonathan B. Ashman, Robert C. Miller, Joerg Herrmann, Abhiram Prasad, Gurpreet S. Sandhu
      Objectives To assess coronary revascularization outcomes in patients with previous thoracic radiation therapy (XRT). Background Previous chest radiation has been reported to adversely affect long term survival in patients with coronary disease treated with percutaneous coronary interventions (PCI). Methods Retrospective, single center cohort study of patients previously treated with thoracic radiation and PCI. Patients were propensity matched against control patients without radiation undergoing revascularization during the same time period. Results We identified 116 patients with radiation followed by PCI (XRT-PCI group) and 408 controls. Acute procedural complications were similar between groups. There were no differences in all-cause and cardiac mortality between groups (all-cause mortality HR 1.31, P =.078; cardiac mortality 0.78, P =.49). Conclusion Patients with prior thoracic radiation and coronary disease treated with PCI have similar procedural complications and long term mortality when compared to control subjects.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.014
      Issue No: Vol. 187 (2017)
       
  • Reduced duration of dual antiplatelet therapy using an improved
           drug-eluting stent for percutaneous coronary intervention of the left main
           artery in a real-world, all-comer population: Rationale and study design
           of the prospective randomized multicenter IDEAL-LM trial
    • Authors: Miguel E. Lemmert; Keith Oldroyd; Paul Barragan; Maciej Lesiak; Robert A. Byrne; Evgeny Merkulov; Joost Daemen; Yoshinobu Onuma; Karen Witberg; Robert-Jan van Geuns
      Pages: 104 - 111
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Miguel E. Lemmert, Keith Oldroyd, Paul Barragan, Maciej Lesiak, Robert A. Byrne, Evgeny Merkulov, Joost Daemen, Yoshinobu Onuma, Karen Witberg, Robert-Jan van Geuns
      Background Continuous improvements in stent technology make percutaneous coronary intervention (PCI) a potential alternative to surgery in selected patients with unprotected left main coronary artery (uLMCA) disease. The optimal duration of dual antiplatelet therapy (DAPT) in these patients remains undetermined, and in addition, new stent designs using a bioabsorbable polymer might allow shorter duration of DAPT. Study design IDEAL-LM is a prospective, randomized, multicenter study that will enroll 818 patients undergoing uLMCA PCI. Patients will be randomized in a 1:1 fashion to intravascular ultrasound-guided PCI with the novel everolimus-eluting platinum-chromium Synergy stent with a biodegradable polymer (Boston Scientific, Natick, MA) followed by 4 months of DAPT or the everolimus-eluting cobalt-chromium Xience stent (Abbott Vascular, Santa Clara, CA) followed by 12 months of DAPT. The total follow-up period will be 5 years. A subset of 100 patients will undergo optical coherence tomography at 3 months. End points The primary end point will be major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization) at 2 years. Secondary end points will consist of the individual components of the primary end point, procedural success, a device-oriented composite end point, stent thrombosis as per Academic Research Consortium criteria, and bleeding as per Bleeding Academic Research Consortium criteria. Summary IDEAL-LM is designed to assess the safety and efficacy of the novel Synergy stent followed by 4 months of DAPT vs the Xience stent followed by 12 months of DAPT in patients undergoing uLMCA PCI. The study will provide novel insights regarding optimal treatment strategy for patients undergoing PCI of uLMCA disease (www.clinicaltrials.gov, NCT 02303717).

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.015
      Issue No: Vol. 187 (2017)
       
  • Rationale and design of the Japan-USA harmonized assessment by randomized,
           multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE):
           Assessment of a novel DES platform for percutaneous coronary
           revascularization in patients with ischemic coronary disease and
           non–ST-elevation acute coronary syndrome
    • Authors: David F. Kong; Shigeru Saito; Shigeru Nakamura; Roxana Mehran; Stephen M. Rowland; Allison Handler; Hussein R. Al-Khalidi; Mitchell W. Krucoff
      Pages: 112 - 121
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): David F. Kong, Shigeru Saito, Shigeru Nakamura, Roxana Mehran, Stephen M. Rowland, Allison Handler, Hussein R. Al-Khalidi, Mitchell W. Krucoff
      Tissue trauma associated with stent implantation continues to generate early thrombosis rates of 0.9% to 1.3% for both bare-metal and drug-eluting stent platforms. The Combo sirolimus-eluting stent combines an abluminal, bioabsorbable polymer with a luminal CD34+ antibody designed to capture endothelial progenitor cells. This article describes the design and methods of the HARMONEE trial (NCT02073565), which represents the first randomized controlled trial of the Combo design against a best-in-class contemporary everolimus-eluting stent. Up to 50 sites in Japan and the United States will enroll 286 subjects (271 evaluable) in each of 2 arms, for a total sample size of 572 subjects (542 evaluable). The statistical plan includes both superiority to imputed bare-metal stent control and noninferiority to everolimus-eluting stent on a primary clinical end point of target vessel failure at 1 year. In addition, fractional flow reserve assessment to evaluate the physiology of target vessels in the entire population will augment the end point definition of ischemia-driven target vessel revascularization. Finally, key safety considerations will be evaluated with a subpopulation with optical coherence tomography imaging for strut coverage, late strut malapposition, and plaque volume, as well as serial human antimurine antibody assessments. As the first international prospective randomized coronary intervention study under the “Harmonization by Doing” program, this study represents a unique collaboration between regulators and investigators in Japan and the United States.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.004
      Issue No: Vol. 187 (2017)
       
  • Atrial fibrillation detected by continuous electrocardiographic monitoring
           using implantable loop recorder to prevent stroke in individuals at risk
           (the LOOP study): Rationale and design of a large randomized controlled
           trial
    • Authors: Søren Zöga Diederichsen; Ketil Jørgen Haugan; Lars Køber; Søren Højberg; Axel Brandes; Christian Kronborg; Claus Graff; Anders Gaarsdal Holst; Jonas Bille Nielsen; Derk Krieger; Jesper Hastrup Svendsen
      Pages: 122 - 132
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Søren Zöga Diederichsen, Ketil Jørgen Haugan, Lars Køber, Søren Højberg, Axel Brandes, Christian Kronborg, Claus Graff, Anders Gaarsdal Holst, Jonas Bille Nielsen, Derk Krieger, Jesper Hastrup Svendsen
      Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non–AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention. Methods The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death. Conclusion The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.017
      Issue No: Vol. 187 (2017)
       
  • Toward evidence-based diagnosis of myocarditis in children and
           adolescents: Rationale, design, and first baseline data of MYKKE, a
           multicenter registry and study platform
    • Authors: Daniel R. Messroghli; Thomas Pickardt; Marcus Fischer; Bernd Opgen-Rhein; Konstantin Papakostas; Dorothée Böcker; André Jakob; Markus Khalil; Goetz C. Mueller; Florian Schmidt; Michael Kaestner; Floris E.A. Udink ten Cate; Robert Wagner; Bettina Ruf; Daniela Kiski; Gesa Wiegand; Franziska Degener; Ulrike M.M. Bauer; Tim Friede; Stephan Schubert
      Pages: 133 - 144
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Daniel R. Messroghli, Thomas Pickardt, Marcus Fischer, Bernd Opgen-Rhein, Konstantin Papakostas, Dorothée Böcker, André Jakob, Markus Khalil, Goetz C. Mueller, Florian Schmidt, Michael Kaestner, Floris E.A. Udink ten Cate, Robert Wagner, Bettina Ruf, Daniela Kiski, Gesa Wiegand, Franziska Degener, Ulrike M.M. Bauer, Tim Friede, Stephan Schubert
      The aim of this registry is to provide data on age-related clinical features of suspected myocarditis and to create a study platform allowing for deriving diagnostic criteria and, at a later stage, testing therapeutic interventions in patients with myocarditis. Study design and results After an initial 6-month pilot phase, MYKKE was opened in June 2014 as a prospective multicenter registry for patients from pediatric heart centers, university hospitals, and community hospitals with pediatric cardiology wards in Germany. Inclusion criteria consisted of age<18 years and hospitalization for suspected myocarditis as leading diagnosis at the discretion of the treating physician. By December 31, 2015, fifteen centers across Germany were actively participating and had enrolled 149 patients. Baseline data reveal 2 age peaks (<2 years, >12 years), show higher proportions of males, and document a high prevalence of severe disease courses in pediatric patients with suspected myocarditis. Severe clinical courses and early adverse events were more prevalent in younger patients and were related to severely impaired leftventricular ejection fraction at initial presentation. Summary MYKKE represents a multicenter registry and research platform for children and adolescents with suspected myocarditis that achieve steady recruitment and generate a wide range of real-world data on clinical course, diagnostic workup, and treatment of this group of patients. The baseline data reveal the presence of 2 age peaks and provide important insights into the severity of disease in children with suspected myocarditis. In the future, MYKKE might facilitate interventional substudies by providing an established collaborating network using common diagnostic approaches.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.027
      Issue No: Vol. 187 (2017)
       
  • Valsartan for attenuating disease evolution in early sarcomeric
           hypertrophic cardiomyopathy: The design of the Valsartan for Attenuating
           Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH)
           trial
    • Authors: Carolyn Y. Ho; John J.V. McMurray; Allison L. Cirino; Steven D. Colan; Sharlene M. Day; Akshay S. Desai; Steven E. Lipshultz; Calum A. MacRae; Ling Shi; Scott D. Solomon; E. John Orav; Eugene Braunwald
      Pages: 145 - 155
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Carolyn Y. Ho, John J.V. McMurray, Allison L. Cirino, Steven D. Colan, Sharlene M. Day, Akshay S. Desai, Steven E. Lipshultz, Calum A. MacRae, Ling Shi, Scott D. Solomon, E. John Orav, Eugene Braunwald
      Hypertrophic cardiomyopathy (HCM) is often caused by sarcomere gene mutations, resulting in left ventricular hypertrophy (LVH), myocardial fibrosis, and increased risk of sudden cardiac death and heart failure. Studies in mouse models of sarcomeric HCM demonstrated that early treatment with an angiotensin receptor blocker (ARB) reduced development of LVH and fibrosis. In contrast, prior human studies using ARBs for HCM have targeted heterogeneous adult cohorts with well-established disease. The VANISH trial is testing the safety and feasibility of disease-modifying therapy with an ARB in genotyped HCM patients with early disease. Methods A randomized, placebo-controlled, double-blind clinical trial is being conducted in sarcomere mutation carriers, 8 to 45 years old, with HCM and no/minimal symptoms, or those with early phenotypic manifestations but no LVH. Participants are randomly assigned to receive valsartan 80 to 320 mg daily (depending on age and weight) or placebo. The primary endpoint is a composite of 9 z-scores in domains representing myocardial injury/hemodynamic stress, cardiac morphology, and function. Total z-scores reflecting change from baseline to final visits will be compared between treatment groups. Secondary endpoints will assess the impact of treatment on mutation carriers without LVH, and analyze the influence of age, sex, and genotype. Conclusions The VANISH trial is testing a new strategy of disease modification for treating sarcomere mutation carriers with early HCM, and those at risk for its development. In addition, further insight into disease mechanisms, response to therapy, and phenotypic evolution will be gained.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.008
      Issue No: Vol. 187 (2017)
       
  • Long-term electrocardiographic safety monitoring in clinical drug
           development: A report from the Cardiac Safety Research Consortium
    • Authors: Jonathan P. Piccini; Richard L. Clark; Peter R. Kowey; Suneet Mittal; Preston Dunnmon; Norman Stockbridge; James A. Reiffel; Mintu P. Turakhia; Paul D. Ziegler; Robert B. Kleiman; Fraz Ismat; Philip Sager
      Pages: 156 - 169
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Jonathan P. Piccini, Richard L. Clark, Peter R. Kowey, Suneet Mittal, Preston Dunnmon, Norman Stockbridge, James A. Reiffel, Mintu P. Turakhia, Paul D. Ziegler, Robert B. Kleiman, Fraz Ismat, Philip Sager
      This white paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding scientific and clinical aspects of long-term electrocardiographic safety monitoring during clinical drug development. To promote multistakeholder discussion of this topic, a Cardiac Safety Research Consortium–sponsored Think Tank was held on 2 December 2015 at the American College of Cardiology's Heart House in Washington, DC. The goal of the Think Tank was to explore how and under what circumstances new and evolving ambulatory monitoring technologies could be used to improve and streamline drug development. This paper provides a detailed summary of discussions at the Think Tank: it does not represent regulatory guidance.

      PubDate: 2017-03-30T07:53:13Z
      DOI: 10.1016/j.ahj.2017.01.012
      Issue No: Vol. 187 (2017)
       
  • Rationale and Design of Family-Based Approach in a Minority Community
           Integrating Systems–Biology for Promotion of Health (FAMILIA)
    • Authors: Sameer Bansilal; Rajesh Vedanthan; Jason C. Kovacic; Ana Victoria Soto; Jacqueline Latina; Johan LM Björkegren; Risa Jaslow; Maribel Santana; Samantha Sartori; Chiara Giannarelli; Venkatesh Mani; Roger Hajjar; Eric Schadt; Andrew Kasarskis; Zahi A. Fayad; Valentin Fuster
      Pages: 170 - 181
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): Sameer Bansilal, Rajesh Vedanthan, Jason C. Kovacic, Ana Victoria Soto, Jacqueline Latina, Johan LM Björkegren, Risa Jaslow, Maribel Santana, Samantha Sartori, Chiara Giannarelli, Venkatesh Mani, Roger Hajjar, Eric Schadt, Andrew Kasarskis, Zahi A. Fayad, Valentin Fuster
      Background The 2020 American Heart Association Impact Goal aims to improve cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular disease and stroke by 20%. A large step toward this goal would be to better understand and take advantage of the significant intersection between behavior and biology across the entire life-span. In the proposed FAMILIA studies, we aim to directly address this major knowledge and clinical health gap by implementing an integrated family-centric health promotion intervention and focusing on the intersection of environment and behavior, while understanding the genetic and biologic basis of cardiovascular disease. Methods We plan to recruit 600 preschool children and their 600 parents or caregivers from 12-15 Head Start schools in Harlem, NY, and perform a 2:1 (2 intervention/1 control) cluster randomization of the schools. The preschool children will receive our intensive 37-hour educational program as the intervention for 4 months. For the adults, those in the “intervention” group will be randomly assigned to 1 of 2 intervention programs: an “individual-focused” or “peer-to-peer based.” The primary outcome in children will be a composite score of knowledge (K), attitudes (A), habits (H), related to body mass index Z score (B), exercise (E), and alimentation (A) (KAH-BEA), using questionnaires and anthropometric measurements. For adults, the primary outcome will be a composite score for behaviors/outcomes related to blood pressure, exercise, weight, alimentation (diet) and tobacco (smoking; Fuster-BEWAT score). Saliva will be collected from the children for SNP genotyping, and blood will be collected from adults for RNA sequencing to identify network models and predictors of primary prevention outcomes. Conclusion The FAMILIA studies seek to demonstrate that targeting a younger age group (3-5 years) and using a family-based approach may be a critical strategy in promoting cardiovascular health across the life-span.

      PubDate: 2017-03-30T07:53:13Z
      DOI: 10.1016/j.ahj.2017.02.020
      Issue No: Vol. 187 (2017)
       
  • Randomized Evaluation of the Effects of Anacetrapib through
           Lipid-modification (REVEAL)—A large-scale, randomized,
           placebo-controlled trial of the clinical effects of anacetrapib among
           people with established vascular disease: Trial design, recruitment, and
           baseline characteristics
    • Authors: M.J. Landray; REVEAL Collaborative Group
      Pages: 182 - 190
      Abstract: Publication date: May 2017
      Source:American Heart Journal, Volume 187
      Author(s): M.J. Landray, REVEAL Collaborative Group
      Patients with prior vascular disease remain at high risk for cardiovascular events despite intensive statin–based treatment. Inhibition of cholesteryl ester transfer protein by anacetrapib reduces low-density lipoprotein (LDL) cholesterol by around 25% to 40% and more than doubles high-density lipoprotein (HDL) cholesterol. However, it is not known if these apparently favorable lipid changes translate into reductions in cardiovascular events. Methods The REVEAL study is a randomized, double-blind, placebo-controlled clinical trial that is assessing the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for an average of at least 4years among patients with preexisting atherosclerotic vascular disease. The primary assessment is an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib on major coronary events (defined as the occurrence of coronary death, myocardial infarction, or coronary revascularization). Results Between August 2011 and October 2013, 30,449 individuals in Europe, North America, and China were randomized to receive anacetrapib 100mg daily or matching placebo. Mean (SD) age was 67 (8) years, 84% were male, 88% had a history of coronary heart disease, 22% had cerebrovascular disease, and 37% had diabetes mellitus. At the randomization visit (after at least 8weeks on a protocol-defined atorvastatin regimen), mean plasma LDL cholesterol was 61 (15) mg/dL and HDL cholesterol was 40 (10) mg/dL. Interpretation The REVEAL trial will provide a robust evaluation of the clinical efficacy and safety of adding anacetrapib to an effective statin regimen. Results are anticipated in 2017.

      PubDate: 2017-03-30T07:53:13Z
      DOI: 10.1016/j.ahj.2017.02.021
      Issue No: Vol. 187 (2017)
       
  • Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF)
           Randomized Trial: Design and Rationale
    • Authors: Richard A. Bernstein; Hooman Kamel; Christopher B. Granger; Robert C. Kowal; Paul D. Ziegler; Lee H. Schwamm
      Abstract: Publication date: Available online 19 April 2017
      Source:American Heart Journal
      Author(s): Richard A. Bernstein, Hooman Kamel, Christopher B. Granger, Robert C. Kowal, Paul D. Ziegler, Lee H. Schwamm
      Background Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the “Stroke of Known Cause and Underlying Atrial Fibrillation” (STROKE-AF) trial. Study design STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12months and up to 3years. Outcomes. The primary objective is to compare the incidence rate of detected AF through 12months of follow-up between the two arms. Conclusion This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.04.007
       
  • Design and rationale for the Influenza vaccination After Myocardial
           Infarction (IAMI) trial. A registry-based randomized clinical trial
    • Authors: Ole Fröbert; Matthias Götberg; Oskar Angerås; Lena Jonasson; David Erlinge; Thomas Engstrøm; Jonas Persson; Svend E. Jensen; Elmir Omerovic; Stefan K. James; Bo Lagerqvist; Johan Nilsson; Amra Kåregren; Rasmus Moer; Cao Yang; David B. Agus; Andrejs Erglis; Lisette O. Jensen; Lars Jakobsen; Evald H. Christiansen; John Pernow
      Abstract: Publication date: Available online 18 April 2017
      Source:American Heart Journal
      Author(s): Ole Fröbert, Matthias Götberg, Oskar Angerås, Lena Jonasson, David Erlinge, Thomas Engstrøm, Jonas Persson, Svend E. Jensen, Elmir Omerovic, Stefan K. James, Bo Lagerqvist, Johan Nilsson, Amra Kåregren, Rasmus Moer, Cao Yang, David B. Agus, Andrejs Erglis, Lisette O. Jensen, Lars Jakobsen, Evald H. Christiansen, John Pernow
      Registry studies and case control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. Methods/Design The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) undergoing coronary angiography will randomly be assigned to either in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI or stent thrombosis at 1year. Implications The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or NSTEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.04.003
       
  • Late outcome of percutaneous mitral commissurotomy: randomized comparison
           of Inoue versus double-balloon technique
    • Authors: Sahmin Lee; Duk-Hyun Kang; Dae-Hee Kim; Jong-Min Song; Jae-Kwan Song; Seong-Wook Park; Seung-Jung Park
      Abstract: Publication date: Available online 18 April 2017
      Source:American Heart Journal
      Author(s): Sahmin Lee, Duk-Hyun Kang, Dae-Hee Kim, Jong-Min Song, Jae-Kwan Song, Seong-Wook Park, Seung-Jung Park
      Background Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25years in a randomized trial. Methods Between 1989 and 1995, 302 patients (77 men, 41±11years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n=152; group I) or double-balloon technique (n=150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3. Results During median follow-up of 20.7years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event-free survival rates at 24years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65–1.20; P =.423). On multivariate analysis, absence of post-PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28–2.63; P =.001) and immediate post-PMC mitral valve area (MVA) <1.8cm2 (HR, 1.53; 95% CI, 1.04–2.25; P =.031) were independently correlated with clinical events after successful PMC. Conclusions The Inoue and double-balloon methods showed similar good clinical outcomes up to 25years, and the achievement of effective commissurotomy to develop post-PMC commissural MR or immediate post-PMC MVA ≥1.8cm2 is important in optimizing the late results of PMC.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.04.004
       
  • Effect of aspirin on renal disease progression in patients with type 2
           diabetes: A multicentre, double-blind, placebo-controlled, randomised
           trial. The LEDA (renaL disEase progression by aspirin in Diabetic
           pAtients) trial. Rationale and study design
    • Authors: Francesco Violi; Giovanni Targher; Annarita Vestri; Roberto Carnevale; Maurizio Averna; Alessio Farcomeni; Andrea Lenzi; Francesco Angelico; Francesco Cipollone; Daniele Pastori
      Abstract: Publication date: Available online 18 April 2017
      Source:American Heart Journal
      Author(s): Francesco Violi, Giovanni Targher, Annarita Vestri, Roberto Carnevale, Maurizio Averna, Alessio Farcomeni, Andrea Lenzi, Francesco Angelico, Francesco Cipollone, Daniele Pastori
      Background Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease (CKD) and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0–2.5ml/min/year. Cyclooxygenase (COX)-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx) B2, are increased in T2DM patients, and are potentially involved in the regulation of renal blood flow. Animal models showed that COX inhibitors, such as aspirin, are associated with improvements in renal plasma flow and eGFR values. Hypothesis The primary endpoint of the LEDA trial is to evaluate the 1-year decline of eGFR in T2DM patients treated or not with low-dose aspirin (100mg/day). Secondary endpoints will be the rapid decline in renal function, defined as a reduction of eGFR ≥5ml/min, and change of renal function class after 1year-follow-up. Furthermore, urinary excretion 11-dehydro-TxB2 will be related to renal function modifications. Study design A phase 3 no-profit, multicentre, double-blind, randomized intervention trial of aspirin 100mg/day vs. placebo (ClinicalTrials.gov Identifier: NCT02895113). All patients will be monitored at 6 and 12months after randomization to assess drug adherence and eGFR changes. Summary The LEDA trial is the first double-blind, placebo-controlled, randomised clinical trial aimed at examining whether aspirin treatment may beneficially affect kidney function in patients with T2DM by reducing the annual eGFR decline. The trial will also examine whether the potential renoprotective effects of aspirin might be partly due to its inhibition of TxB2 production.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.04.005
       
  • Impact of AHA's 2007 guideline change on incidence of Infective
           Endocarditis in Infants and Children
    • Authors: Rie Sakai Bizmark; Ruey-Kang R. Chang; Yusuke Tsugawa; Kenneth M. Zangwill; Ichiro Kawachi
      Abstract: Publication date: Available online 18 April 2017
      Source:American Heart Journal
      Author(s): Rie Sakai Bizmark, Ruey-Kang R. Chang, Yusuke Tsugawa, Kenneth M. Zangwill, Ichiro Kawachi
      Objectives Use a nationally-representative sample to assess impacts of new clinical guidelines issued by the American Heart Association (AHA) in 2007 for many types of invasive procedures, with recommendations for significant decreases in antimicrobial prophylaxis use. Study Design Interrupted time series analyses of pediatric hospitalizations for Infective Endocarditis (IE), using the Nationwide Inpatient Sample (NIS) ICD-9-CM diagnostic codes, identified IE hospitalizations for patients <18 y/o from 2001–2012. IE incidence changes before and after 2007 AHA guidelines were evaluated, with differences in IE clinical severity assessed using in-hospital mortality and length of stay. Analyses were stratified by pathogen type and age group (0–9 y/o and 10–17 y/o). Results With 3,748 patients in the study, we observed rising trends in IE incidence, but no significant difference between pre- and post-guideline. There was a significant trend increase for IE due to viridans group streptococci (VGS) for ages >10 y/o, comparing pre-guideline to post-guideline periods, but not in children 0–9 years of age. Neither in-hospital mortality nor length of stay changed significantly during study. Conclusions The data did not demonstrate an impact of the 2007 guideline changes on overall incidence of pediatric IE. However, a significant increase in disease incidence trend due to VGS was observed for the 10–17 y/o group, compared pre- and post-guideline.

      PubDate: 2017-04-20T20:40:18Z
      DOI: 10.1016/j.ahj.2017.04.006
       
  • Seasonal and Circadian Variations of Acute Myocardial Infarction: Findings
           from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD)
           Program
    • Authors: Vijaiganesh Nagarajan; Gregg Fonarow Christine Michael Pencina Warren Laskey Thomas
      Abstract: Publication date: Available online 12 April 2017
      Source:American Heart Journal
      Author(s): Vijaiganesh Nagarajan, Gregg C. Fonarow, Christine Ju, Michael Pencina, Warren K. Laskey, Thomas M. Maddox, Adrian Hernandez, Deepak L. Bhatt
      Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. We also investigated the peak time of admission to better understand the circadian rhythm. Methods Data from Get With The Guidelines – Coronary Artery Disease (GWTG-CAD) database were used. We analyzed 82,971 consecutive acute myocardial infarction (AMI) patients treated at 276 US centers from 2003 to 2008. The country was geographically divided into warmer southern and colder northern states using latitude 35 degrees for this purpose. Results Overall, acute myocardial infarction (AMI) admissions varied across seasons (P <.01), and were higher in winter (winter vs. spring n=21,483 vs. 20,291, respectively). When stratified based on type of AMI, non-ST segment elevation myocardial infarction (NSTEMI) admissions varied across seasons (P <.01) and were highest in winter and lowest in spring. Seasonal variation was not significant in STEMI admissions (P =.30). Seasonal variation with winter predominance was noted in AMI patients in warmer southern states (P <.01), but not in colder states. The distributions of length of stay for AMI patients and door to balloon times for STEMI patients were minimally different across all four seasons (P <.01) with longest occurring in winter. Most patients with AMI presented during daytime with a peak close to 11am and a nadir at approximately 4am. Conclusions Seasonal variation with winter predominance exists in AMI admissions and was significant in NSTEMI admissions but not in STEMI admissions. Seasonal variation was only significant in warmer southern states.

      PubDate: 2017-04-13T20:33:33Z
       
  • Utilization of Cardiac Resynchronization Therapy in Eligible Patients
           Hospitalized for Heart Failure and Its Association with Patient Outcomes
    • Authors: Tiffany C. Randolph; Anne S. Hellkamp; Emily P. Zeitler; Gregg C. Fonarow; Adrian F. Hernandez; Kevin L. Thomas; Eric D. Peterson; Clyde W. Yancy; Sana M. Al-Khatib
      Abstract: Publication date: Available online 6 April 2017
      Source:American Heart Journal
      Author(s): Tiffany C. Randolph, Anne S. Hellkamp, Emily P. Zeitler, Gregg C. Fonarow, Adrian F. Hernandez, Kevin L. Thomas, Eric D. Peterson, Clyde W. Yancy, Sana M. Al-Khatib
      Objectives We examined trends in CRT utilization overall and by sex and race and to assess whether CRT use is associated with a reduction in HF hospitalization and mortality. Background It is unknown whether underutilization and race/sex-based differences in cardiac resynchronization therapy (CRT) use have persisted. The association between CRT and heart failure (HF) hospitalization and mortality in real-world practice remains unclear. Methods We linked 72,008 HF patients from 388 hospitals participating in Get With The Guidelines HF eligible for CRT with Centers for Medicare & Medicaid Services data to assess CRT utilization trends, HF hospitalization rates, and all-cause mortality. Results From 2005–2014, 18,935 (26.3%) eligible patients had CRT in place, implanted, or prescribed. The majority were male (60.0%) and white (61.9%). CRT utilization increased during the study period (p=0.0002) especially in the early period. Women were less likely to receive CRT, and this difference increased over time (interaction p=0.0037) despite greater mortality risk reduction (interaction p=0.0043). Black patients were less likely than white patients to have CRT throughout the study period (adjusted hazard ratio (HR) 0.79; 95% Confidence Interval (CI) 0.74, 0.85). Patients with CRT implanted during the index hospitalization had lower mortality (adjusted HR 0.65; 95% CI 0.59, 0.71) and were less likely to be readmitted for HF than patients without CRT (adjusted HR 0.64; 95% CI 0.58, 0.71). Conclusions/relevance CRT use has increased in all populations, but remains underutilized. CRT remains more common among white than black HF patients, and women were less likely than men to receive CRT despite deriving greater benefit.

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.04.001
       
  • Prognostication on the Spot! The Evolving Importance of Urinary Creatinine
           in Heart Failure
    • Authors: Meredith A. Brisco-Bacik
      Abstract: Publication date: Available online 4 April 2017
      Source:American Heart Journal
      Author(s): Meredith A. Brisco-Bacik


      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.03.021
       
  • Reliability of Updated Left Ventricular Diastolic Function Recommendations
           in Predicting Elevated Left Ventricular Filling Pressure and Prognosis
    • Authors: Kimi Sato; Andrew D.M. Grant; Kazuaki Negishi; Paul C. Cremer; Tomoko Negishi; Arnav Kumar; Patrick Collier; Samir R. Kapadia; Richard A. Grimm; Milind Y. Desai; Brian P. Griffin; Zoran B. Popović
      Abstract: Publication date: Available online 4 April 2017
      Source:American Heart Journal
      Author(s): Kimi Sato, Andrew D.M. Grant, Kazuaki Negishi, Paul C. Cremer, Tomoko Negishi, Arnav Kumar, Patrick Collier, Samir R. Kapadia, Richard A. Grimm, Milind Y. Desai, Brian P. Griffin, Zoran B. Popović
      Background An updated 2016 echocardiographic algorithm for diagnosing left ventricular (LV) diastolic dysfunction (DD) was recently proposed. We aimed to assess the reliability of the 2016 echocardiographic LVDD grading algorithm in predicting elevated LV filling pressure and clinical outcomes compared to the 2009 version. Methods We retrospectively identified 460 consecutive patients without atrial fibrillation or significant mitral valve disease who underwent transthoracic echocardiography within 24hours of elective heart catheterization. LV end-diastolic pressure (LVEDP) and the time constant of isovolumic pressure decay (Tau) were determined. The association between DD grading by 2009 LVDD Recommendations and 2016 Recommendations with hemodynamic parameters and all-cause mortality were compared. Results The 2009 LVDD Recommendations classified 55 patients (12%) as having normal, 132 (29%) as grade 1, 156 (34%) as grade 2, and 117 (25%) as grade 3 DD. Based on 2016 Recommendations, 177 patients (38%) were normal, 50 (11%) were indeterminate, 124 (27%) patients were grade 1, 75 (16%) were grade 2, 26 (6%) were grade 3 DD, and 8 (2%) were cannot determine. The 2016 Recommendations had superior discriminatory accuracy in predicting LVEDP (P <.001) but were not superior in predicting Tau. During median follow-up of 416days (interquartile range: 5 to 2004days), 54 patients (12%) died. Significant DD by 2016 Recommendations was associated with higher risk of mortality (P =.039, subdistribution HR1.85 [95%CI: 1.03–3.33]) in multivariable competing risk regression. Conclusions The grading algorithm proposed by the 2016 LV diastolic dysfunction Recommendations detects elevated LVEDP and poor prognosis better than the 2009 Recommendations.

      PubDate: 2017-04-06T14:11:35Z
      DOI: 10.1016/j.ahj.2017.03.022
       
  • True Rate of Mineralocorticoid Receptor Antagonists-related Hyperkalemia
           in Placebo-Controlled Trials: A Meta-Analysis
    • Authors: Davor Vukadinović; Daniel Lavall; Aleksandra Nikolovska Vukadinović; Bertram Pitt; Stefan Wagenpfeil; Michael Böhm
      Abstract: Publication date: Available online 23 March 2017
      Source:American Heart Journal
      Author(s): Davor Vukadinović, Daniel Lavall, Aleksandra Nikolovska Vukadinović, Bertram Pitt, Stefan Wagenpfeil, Michael Böhm
      Background Mineralocorticoid receptor antagonists (MRA) improve survival in heart failure with reduced ejection fraction but are often underused, mostly due to concerns of hyperkalemia. Because hyperkalemia occurs also on placebo, we aimed to determine the truly MRA-related rate of hyperkalemia. Methods We performed a meta-analysis including randomized, placebo-controlled trials reporting hyperkalemia on MRAs in patients after myocardial infarction or with chronic heart failure. We evaluated the truly MRA-related rate of hyperkalemia that represents hyperkalemia on MRA, corrected for hyperkalemia on placebo (Pla), according to the equation: True MRA (%)=(MRA (%) – Pla (%)) / MRA (%). Results A total number of 16,065 patients from seven trials were analyzed. Hyperkalemia was more frequently observed on MRA (9.3%) vs. placebo (4.3%) (Risk Ratio (RR) 2.17, 95% confidence interval (CI) 1.92–2.45; P <.0001). Truly MRA-related hyperkalemia was 54% while 46% were non-MRA-related. In trials using eplerenone, hyperkalemia was documented in 5.0% on eplerenone and in 2.6% on placebo (P <.0001). In spironolactone trials, hyperkalemia was documented in 17.5% and in 7.5% of patients on placebo (P =.0001). Hypokalemia occurred less frequently in patients on MRA (9.3%) compared to placebo (14.8%) (RR 0.58, CI 0.47–0.72, P <.0001). Conclusion This meta-analysis shows that in clinical trials, 54% of hyperkalemia cases were specifically related to the MRA treatment and 46% to other reasons. Therefore, non MRA-related rises in potassium levels might be underestimated and should be rigorously explored before cessation of the evidence-based therapy with MRAs.

      PubDate: 2017-03-30T07:53:13Z
      DOI: 10.1016/j.ahj.2017.03.011
       
  • Lisinopril or Coreg CR in Reducing Cardiotoxicity in Women with Breast
           Cancer Receiving Trastuzumab: a Rationale and Design of a Randomized
           Clinical Trial
    • Authors: Maya Guglin; Pamela Munster; Angelina Fink; Jeffrey Krischer
      Abstract: Publication date: Available online 22 March 2017
      Source:American Heart Journal
      Author(s): Maya Guglin, Pamela Munster, Angelina Fink, Jeffrey Krischer
      Background Trastuzumab (TZB) is an established therapy for HER2 positive breast cancer. The use of TZB is commonly associated with cardiotoxicity manifesting as asymptomatic decrease in left ventricular ejection fraction (LVEF) or overt heart failure. Several studies demonstrated favorable effects of angiotensin converting enzyme (ACE) inhibitors and beta blockers (BB) in the prevention of chemotherapy-induced cardiotoxicity. We hypothesize that patients, randomized to receive an ACE inhibitor or a beta-blocker during trastuzumab therapy for breast cancer, will maintain a higher LVEF than patients randomized to placebo. Methods and Results We designed a prospective, multicenter, randomized, phase II placebo-controlled clinical trial to evaluate the effects of an ACE inhibitor (lisinopril) and a β-blocker (carvedilol phosphate-extended release) on cardiotoxicity in patients with breast cancer who are receiving adjuvant or neoadjuvant TZB therapy. The primary objectives include 1) comparison of incidence of cardiotoxicity and 2) comparison of LVEF as a continuous variable in between the arms. Cardiotoxicity was defined as an absolute decrease in LVEF from baseline of ≥10% at follow-up or an absolute decrease of ≥5% in LVEF from baseline for individuals with <50% LVEF at follow-up. The target accrual is 468 participants, representing patients both with and without anthracycline exposure. The enrollment is completed. The trial is co-sponsored by University of South Florida and National Cancer Institute. The LVEF is being evaluated by echocardiography or multigated acquisition scan. Conclusion If we can demonstrate that the use of an ACE inhibitor or a BB can reduce the degree of TZB-induced cardiotoxicity it is hoped that patients will receive complete and uninterrupted TZB therapy for breast cancer without compromising cardiac function. Clinical trial registration SCUSF 0806 NCT01009918 (url https://clinicaltrials.gov/ct2/show/NCT01009918).

      PubDate: 2017-03-23T07:39:56Z
      DOI: 10.1016/j.ahj.2017.03.010
       
  • A Laboratory Association between Hemoglobin and VerifyNow P2Y12 Reaction
           Unit: a Systematic Review and Meta-Analysis
    • Authors: Yun Gi Kim; Jung-Won Suh; Dirk Sibbing; Adnan Kastrati; Young-Guk Ko; Yangsoo Jang; Young-Seok Cho; Tae-Jin Youn; In-Ho Chae; Dong-Ju Choi; Hyo-Soo Kim
      Abstract: Publication date: Available online 15 March 2017
      Source:American Heart Journal
      Author(s): Yun Gi Kim, Jung-Won Suh, Dirk Sibbing, Adnan Kastrati, Young-Guk Ko, Yangsoo Jang, Young-Seok Cho, Tae-Jin Youn, In-Ho Chae, Dong-Ju Choi, Hyo-Soo Kim
      Background VerifyNow P2Y12 assay is used widely to evaluate residual platelet reactivity in patients taking P2Y12 receptor antagonists. However, a laboratory association between VerifyNow P2Y12 reaction unit (PRU) and hemoglobin, which might lead to wrong interpretation of the data, is reported. We performed this systematic review and meta-analysis to clearly define the relationship between PRU and hemoglobin and to elucidate whether the relationship, if any, is a true biological association or is just a laboratory error. Methods Through a comprehensive electronic and manual search, ten studies were selected for the cohort level meta-analysis. Among ten studies, we were able to retrieve the raw data of five studies and a patient level meta-analysis was performed. Potential publication bias was searched by funnel plot analysis and was actively adjusted, if present, by trim and fill method. Results The pooled analysis revealed a significant inverse correlation between PRU and hemoglobin (r=-0.349; p<0.001; ten studies with 4,793 patients). VerifyNow P2Y12 base unit, which reflects off-drug platelet reactivity, was also inversely correlated with hemoglobin (r=-0.526; p<0.001; eight studies with 4,395 patients). % Inhibition (r=0.081; p=0.059; six studies with 3,832 patients) and ΔPRU (r=-0.037; p=0.188; five studies with 3,521 patients) was not associated with hemoglobin. A significant inverse association between PRU and hemoglobin was also observed in the patient level meta-analysis (3,533 patients pooled from five studies; r=-0.335; p<0.001). Light transmission aggregometry (r=0.160; p=0.072; four studies with 1,144 patients) and multiple electrode platelet aggregometry (r=-0.029; p=0.394; three studies with 7,645 patients) showed no significant association with hemoglobin. Conclusions A significant inverse association was observed between PRU and hemoglobin which is likely to be a laboratory error. Clinicians should be aware that this association might lead to wrong interpretation of the data.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.03.006
       
  • The effects of sacubitril/valsartan on coronary outcomes in PARADIGM-HF
    • Authors: Ulrik M. Mogensen; Lars Køber; Søren L. Kristensen; Pardeep S. Jhund; Jianjian Gong; Martin P. Lefkowitz; Adel R. Rizkala; Jean L. Rouleau; Victor C. Shi; Karl Swedberg; Michael R. Zile; Scott D. Solomon; Milton Packer; John J.V. McMurray
      Abstract: Publication date: Available online 14 March 2017
      Source:American Heart Journal
      Author(s): Ulrik M. Mogensen, Lars Køber, Søren L. Kristensen, Pardeep S. Jhund, Jianjian Gong, Martin P. Lefkowitz, Adel R. Rizkala, Jean L. Rouleau, Victor C. Shi, Karl Swedberg, Michael R. Zile, Scott D. Solomon, Milton Packer, John J.V. McMurray
      Background Angiotensin converting enzyme inhibitors (ACE-I), are beneficial both in heart failure with reduced ejection fraction (HF-REF) and after myocardial infarction (MI). We examined the effects of the angiotensin-receptor neprilysin inhibitor sacubitril/valsartan, compared with the ACE-I enalapril, on coronary outcomes in PARADIGM-HF. Methods and results We examined the effect of sacubitril/valsartan compared with enalapril on the following outcomes: i) the primary composite endpoint of cardiovascular (CV) death or HF hospitalization, ii) a pre-defined broader composite including, in addition, MI, stroke, and resuscitated sudden death, and iii) a post hoc coronary composite of CV-death, non-fatal MI, angina hospitalization or coronary revascularization. At baseline, of 8399 patients, 3634 (43.3%) had a prior MI and 4796 (57.1%) had a history of any coronary artery disease. Among all patients, compared with enalapril, sacubitril/valsartan reduced the risk of the primary outcome (HR=0.80 [0.73–0.87], P <.001), the broader composite (HR=0.83 [0.76–0.90], P <.001) and the coronary composite (HR=0.83 [0.75–0.92], P <.001). Although each of the components of the coronary composite occurred less frequently in the sacubitril/valsartan group, compared with the enalapril group, only CV death was reduced significantly. Conclusions Compared with enalapril, sacubitril/valsartan reduced the risk of both the primary endpoint and a coronary composite outcome in PARADIGM-HF. Additional studies on the effect of sacubitril/valsartan on atherothrombotic outcomes in high risk patients are merited.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.02.034
       
  • Does perceived stress increase the risk of atrial fibrillation' A
           population-based cohort study in Denmark
    • Authors: Simon Graff; Anders Prior; Morten Fenger-Grøn; Bo Christensen; Charlotte Glümer; Finn Breinholt Larsen; Mogens Vestergaard
      Abstract: Publication date: Available online 12 March 2017
      Source:American Heart Journal
      Author(s): Simon Graff, Anders Prior, Morten Fenger-Grøn, Bo Christensen, Charlotte Glümer, Finn Breinholt Larsen, Mogens Vestergaard
      Background Psychological stress is associated with increased risk of acute cardiovascular diseases, as myocardial infarction. We recently found a higher risk of atrial fibrillation following an acute stressful life event, but it remains unknown whether this also applies to common and less acute stress exposures. Methods We investigated the risk of incident atrial fibrillation in people with high levels of perceived stress by following a population-based cohort of 114,337 participants from the Danish National Health Survey from 2010 to 2014. The survey holds information on lifestyle factors and perceived stress measured by Cohen’s 10-item Perceived Stress Scale (PSS). We obtained information on atrial fibrillation, comorbidities and socioeconomic status from Danish nationwide registers. We identified 2,172 persons with a first episode of atrial fibrillation during 424,839 person-years of follow-up. The hazard ratio (HR) of atrial fibrillation with 95% confidence interval (CI) was calculated with Cox proportional hazard model. Results The risk of atrial fibrillation increased with increasing PSS score; persons in the highest perceived stress quintile had 28% (95% CI; 12% to 46%) higher risk of atrial fibrillation compared with persons in the lowest perceived stress quintile. However, the association disappeared when adjusting for comorbidities, socioeconomic status and lifestyle factors; HR was 1.01 (95 % CI; 0.88 to 1.16) when comparing persons in the highest and the lowest perceived stress quintile. Conclusions This large population-based cohort study did not reveal a higher risk of atrial fibrillation among persons with a high degree of perceived stress after adjustment for participants’ baseline characteristics.

      PubDate: 2017-03-18T07:28:07Z
      DOI: 10.1016/j.ahj.2017.03.002
       
  • Results of a Phase I/II Multi-Center Investigation of Udenafil in
           Adolescents after Fontan Palliation
    • Authors: David J. Goldberg; Victor Zak; Bryan H. Goldstein; Shan Chen; Michelle S. Hamstra; Elizabeth A. Radojewski; Eileen Maunsell; Seema Mital; Shaji C. Menon; Kurt R. Schumacher; R. Mark Payne; Mario Stylianou; Jonathan R. Kaltman; Tina M. deVries; James L. Yeager; Stephen M. Paridon
      Abstract: Publication date: Available online 6 March 2017
      Source:American Heart Journal
      Author(s): David J. Goldberg, Victor Zak, Bryan H. Goldstein, Shan Chen, Michelle S. Hamstra, Elizabeth A. Radojewski, Eileen Maunsell, Seema Mital, Shaji C. Menon, Kurt R. Schumacher, R. Mark Payne, Mario Stylianou, Jonathan R. Kaltman, Tina M. deVries, James L. Yeager, Stephen M. Paridon
      Background The Fontan operation results in a circulation that is dependent on low pulmonary vascular resistance to maintain an adequate cardiac output. Medical therapies that lower pulmonary vascular resistance may augment cardiac output and improve long-term outcomes. Objectives This phase I/II clinical trial conducted by the Pediatric Heart Network was designed to evaluate short-term safety, pharmacokinetics (PK), and preliminary efficacy of udenafil in adolescents following Fontan. Methods A 5-day dose-escalation trial was conducted in five study cohorts of six subjects each (37.5, 87.5, and 125mg daily, 37.5 and 87.5mg by mouth twice daily). A control cohort with 6 subjects underwent exercise testing only. Adverse events (AEs) were recorded, PK samples were collected on study days six through eight, and clinical testing was performed at baseline and day five. Results The trial enrolled 36 subjects; mean age 15.8years (58% male). There were no significant differences in subject characteristics between cohorts. No drug-related serious AEs were reported during the study period; 24 subjects had AEs possibly or probably related to study drug. Headache was the most common AE, occurring in 20 of 30 subjects. The 87.5mg bid cohort was well tolerated, achieved the highest maximal concentration (506ng/mL) and the highest average concentration over the dosing interval (279ng/mL), and was associated with a suggestion of improvement in myocardial performance. Exercise performance did not improve in any of the dosing cohorts. Conclusions Udenafil was well-tolerated at all dosing levels. The 87.5mg bid cohort achieved the highest plasma drug level and was associated with a suggestion of improvement in myocardial performance. These data suggest that the 87.5mg bid regimen may be the most appropriate for a Phase III clinical trial.

      PubDate: 2017-03-11T11:01:17Z
      DOI: 10.1016/j.ahj.2017.02.030
       
  • Compliance with Guideline Directed Therapy in Diabetic Patients Admitted
           with Acute Coronary Syndrome: Findings from AHA Get With the Guidelines
           – Coronary Artery Disease Program
    • Authors: Prakash Deedwania; Tushar Acharya; Kamal Kotak; Gregg C Fonarow; Christopher P Cannon; Warren K Laskey; W Frank Peacock; Wenqin Pan; Deepak L Bhatt
      Abstract: Publication date: Available online 23 February 2017
      Source:American Heart Journal
      Author(s): Prakash Deedwania, Tushar Acharya, Kamal Kotak, Gregg C Fonarow, Christopher P Cannon, Warren K Laskey, W Frank Peacock, Wenqin Pan, Deepak L Bhatt
      Background To evaluate and compare baseline characteristics, outcomes and compliance with guideline based therapy at discharge among diabetic and non-diabetic patients admitted with acute coronary syndromes (ACS). Methods and Results Study population consisted of 151,270 patients admitted with ACS from 2002 through 2008 at 411 sites participating in the AHA Get With The Guidelines (GWTG) program. Demographic variables, physical exam findings, laboratory data, left ventricular ejection fraction, length of stay, in-hospital mortality and discharge medications were compared between diabetic and non-diabetic patients. Temporal trends in compliance with guidelines directed therapy were evaluated. Of 151,270 patients, 48,938 (32%) had diabetes. Overall, diabetic patients were significantly older and more likely non-white. They had significantly more hypertension, atherosclerotic disease, CKD, LV dysfunction and were more likely to present as NSTEMI. They had longer hospital stay and higher hospital mortality than non-diabetic patients. Diabetic patients were less likely to get LDL checks (65% vs 70%) and less frequently prescribed statins (85% vs 89%), RAAS blockers for LV dysfunction (80% vs 84%) and dual-antiplatelet therapy (69% vs 74%). Diabetic patients were less likely to achieve BP goals before discharge (75% vs 82%). Fewer diabetic patients met first medical contact to PCI time for STEMI (44% vs 52%). Temporal trends, however, showed continued progressive improvement in most performance measures from 2002 to 2008 (all P <.001). Conclusions These data from a large cohort of ACS patients demonstrate gaps in compliance with guidelines directed therapy in diabetic patients but also indicate significant and continued improvement in most performance measures over time. Concerted efforts are needed to continue this positive trend.

      PubDate: 2017-02-26T10:23:15Z
      DOI: 10.1016/j.ahj.2017.02.025
       
  • Day vs. Night: Does time of presentation matter in Acute Heart
           Failure' A secondary analysis from the RELAX-AHF Trial
    • Authors: Peter S. Pang; John R. Teerlink; Leandro Boer-Martins; Claudio Gimpelewicz; Beth A. Davison; Yi Wang; Adriaan A. Voors; Thomas Severin; Piotr Ponikowski; Tsushung A. Hua; Barry H. Greenberg; Gerasimos Filippatos; G. Michael Felker; Gad Cotter; Marco Metra
      Abstract: Publication date: Available online 22 February 2017
      Source:American Heart Journal
      Author(s): Peter S. Pang, John R. Teerlink, Leandro Boer-Martins, Claudio Gimpelewicz, Beth A. Davison, Yi Wang, Adriaan A. Voors, Thomas Severin, Piotr Ponikowski, Tsushung A. Hua, Barry H. Greenberg, Gerasimos Filippatos, G. Michael Felker, Gad Cotter, Marco Metra
      Background Signs and symptoms of heart failure can occur at any time. Differences between acute heart failure (AHF) patients who present at nighttime vs. daytime and their outcomes have not been well studied. Our objective was to determine if there are differences in baseline characteristics and clinical outcomes between AHF patients presenting during daytime vs. nighttime hours within an international, clinical trial. Methods This is a post-hoc analysis of the RELAX AHF trial, which randomized 1161 AHF patients to serelaxin vs. placebo, both in addition to usual AHF therapy. Pre-specified end points of the primary trial were used: dyspnea, 60-day HF/RF (heart failure/renal failure) re-hospitalization or cardiovascular (CV) death, and 180-day CV death. Both unadjusted and adjusted analyses for outcomes stratified by daytime vs. nighttime presentation were performed. Results Of the 1161 RELAX-AHF patients, 775 (66.8%) patients presented during daytime and 386 (33.2%) at nighttime. Baseline characteristics were largely similar, though daytime patients were more likely to be male, have greater baseline body weight, higher NYHA class, history of atrial fibrillation, and more peripheral edema than nighttime patients. No differences in dyspnea relief or 60-day outcomes were observed. However, daytime presentation was associated with greater risk for 180-day CV death after adjustment (HR 2.28, 95% CI 1.34–3.86; c-statistic 0.82 (95%CI 0.78–0.86)). Conclusion In this secondary analysis of the RELAX-AHF trial, baseline characteristics suggest daytime presenting patients may be more gradual worsening of chronic heart failure. AHF patients who presented at night had less risk for 180-day CV death, but similar risk for 60-day CV death or re-hospitalization and symptom improvement as patients who presented during the daytime.

      PubDate: 2017-02-26T10:23:15Z
      DOI: 10.1016/j.ahj.2017.02.024
       
  • Determinants of operator radiation exposure during percutaneous coronary
           procedures
    • Authors: Alessandro Sciahbasi; Stefano Rigattieri; Alessandro Sarandrea; Maria Cera; Cristian Di Russo; Silvio Fedele; Roberto Patrizi; Silvio Romano; Francesco Rocco Pugliese; Maria Penco; Samir B Pancholy
      Abstract: Publication date: Available online 17 February 2017
      Source:American Heart Journal
      Author(s): Alessandro Sciahbasi, Stefano Rigattieri, Alessandro Sarandrea, Maria Cera, Cristian Di Russo, Silvio Fedele, Roberto Patrizi, Silvio Romano, Francesco Rocco Pugliese, Maria Penco, Samir B Pancholy
      Background Radiation exposure is an important issue for interventional cardiologists that is often underevaluated. Our aim was to evaluate determinants of operator radiation exposure during percutaneous coronary procedures. Methods The RADIANT (NCT01974453) is a prospective, single centre observational study involving four expert operators and two fellows performing percutaneous coronary procedures. The operator radiation dose was evaluated using dedicated electronic dosimeters in 2028 procedures: 1897 transradial access (TRA) (1120 right and 777 left TRA) and 131 transfemoral access (TFA). Results In the whole population operator radiation dose at thorax did not differ between TFA (9μSv [interquartile range 5–18μSv]) and TRA (9μSv [4–21μSv]) but after propensity score matching analysis, TFA showed lower dose (9μSv [5–18μSv]) compared to TRA (17μSv [9–28μSv], P <.001). In the whole transradial group, left TRA (5μSv [2–12μSv]) was associated with significant lower operator dose compared to right TRA (13μSv [6–26μSv], P <.001).The use of adjunctive protective pelvic drapes was significantly associated with lower radiation doses compared to procedures performed without drapes (P <.001). Among the operators, an inverse relation between height and dose was observed. Finally, left projections, the use of angiographic systems not dedicated for coronary and high frame rates were all associated with a significant higher operator radiation exposure. Conclusions In a high volume centre for transradial procedures, TFA is associated with lower operator radiation dose compared to TRA. The use of adjunctive anti-rx drapes seems a valuable tool to reduce the higher operator radiation exposure associated with TRA.
      Graphical abstract image

      PubDate: 2017-02-20T10:32:08Z
      DOI: 10.1016/j.ahj.2017.02.012
       
  • Baseline Characteristics of Patients Enrolled in the Exenatide Study of
           Cardiovascular Event Lowering (EXSCEL)
    • Authors: Robert J. Mentz; M. Angelyn Bethel; Stephanie Gustavson; Vivian P. Thompson; Neha J. Pagidipati; John B. Buse; Juliana C. Chan; Nayyar Iqbal; Aldo P. Maggioni; Steve P. Marso; Peter Ohman; Neil Poulter; Ambady Ramachandran; Bernard Zinman; Adrian F. Hernandez; Rury R. Holman
      Abstract: Publication date: Available online 12 February 2017
      Source:American Heart Journal
      Author(s): Robert J. Mentz, M. Angelyn Bethel, Stephanie Gustavson, Vivian P. Thompson, Neha J. Pagidipati, John B. Buse, Juliana C. Chan, Nayyar Iqbal, Aldo P. Maggioni, Steve P. Marso, Peter Ohman, Neil Poulter, Ambady Ramachandran, Bernard Zinman, Adrian F. Hernandez, Rury R. Holman
      Background EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. Methods Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. Results A total of 14,752 participants randomized between June 2010 and September 2015, 6788 (46.0%) patients were enrolled in Europe, 3708 (25.1%) North America, 2727 (18.5%) Latin America, and 1529 (10.4%) Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). Conclusions EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

      PubDate: 2017-02-13T10:23:42Z
      DOI: 10.1016/j.ahj.2017.02.005
       
 
 
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