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Publisher: Elsevier   (Total: 3043 journals)

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Showing 1 - 200 of 3043 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: 18, SJR: 1.008, h-index: 75)
Accident Analysis & Prevention     Partially Free   (Followers: 83, SJR: 1.109, h-index: 94)
Accounting Forum     Hybrid Journal   (Followers: 23, 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: 333, 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   (Followers: 1)
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: 225, 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: 23, SJR: 1.365, h-index: 73)
Acta Sociológica     Open Access  
Acta Tropica     Hybrid Journal   (Followers: 6, 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: 4, 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: 3)
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: 8, SJR: 1.039, h-index: 5)
Additives for Polymers     Full-text available via subscription   (Followers: 20)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 134, 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: 9, 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: 25, 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: 22, 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: 25, 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: 10, 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: 42, 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: 40, 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: 47, SJR: 0.674, h-index: 38)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 15)
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: 21, 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: 26)
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: 35, 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: 5)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 4)
Advances in Life Course Research     Hybrid Journal   (Followers: 8, SJR: 0.764, h-index: 15)
Advances in Lipobiology     Full-text available via subscription   (Followers: 2)
Advances in Magnetic and Optical Resonance     Full-text available via subscription   (Followers: 9)
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: 6, 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: 22)
Advances in Molecular and Cellular Endocrinology     Full-text available via subscription   (Followers: 10)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 7, SJR: 0.324, h-index: 8)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 4)
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: 24, SJR: 0.4, h-index: 28)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 13)
Advances in Pharmacology     Full-text available via subscription   (Followers: 15, 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: 19, SJR: 1.5, h-index: 62)
Advances in Psychology     Full-text available via subscription   (Followers: 60)
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: 2, SJR: 0.1, h-index: 2)
Advances in Space Research     Full-text available via subscription   (Followers: 345, SJR: 0.606, h-index: 65)
Advances in Structural Biology     Full-text available via subscription   (Followers: 8)
Advances in Surgery     Full-text available via subscription   (Followers: 7, SJR: 0.823, h-index: 27)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 30, SJR: 1.321, h-index: 56)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 16)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 13)
Advances in Virus Research     Full-text available via subscription   (Followers: 5, SJR: 1.878, h-index: 68)
Advances in Water Resources     Hybrid Journal   (Followers: 43, 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: 310, 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: 5, SJR: 0.344, h-index: 6)
Ageing Research Reviews     Hybrid Journal   (Followers: 8, SJR: 3.289, h-index: 78)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 408, 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: 30, SJR: 1.275, h-index: 74)
Agricultural Water Management     Hybrid Journal   (Followers: 38, 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: 53, 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: 5, 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: 6)
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: 8, 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: 4, 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: 7, SJR: 0.158, h-index: 9)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 48, 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: 48, SJR: 3.157, h-index: 153)
American J. of Cardiology     Hybrid Journal   (Followers: 45, SJR: 2.063, h-index: 186)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 38, 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: 16, SJR: 1.653, h-index: 93)
American J. of Human Genetics     Hybrid Journal   (Followers: 31, SJR: 8.769, h-index: 256)
American J. of Infection Control     Hybrid Journal   (Followers: 24, SJR: 1.259, h-index: 81)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 33, SJR: 2.313, h-index: 172)
American J. of Medicine     Hybrid Journal   (Followers: 46, 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: 187, SJR: 2.255, h-index: 171)
American J. of Ophthalmology     Hybrid Journal   (Followers: 54, SJR: 2.803, h-index: 148)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 3)
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: 23, SJR: 0.59, h-index: 45)
American J. of Pathology     Hybrid Journal   (Followers: 26, 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: 34, SJR: 1.286, h-index: 125)
American J. of the Medical Sciences     Hybrid Journal   (Followers: 12, 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: 55, SJR: 0.124, h-index: 9)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 9)
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: 164, SJR: 0.725, h-index: 154)
Analytical Chemistry Research     Open Access   (Followers: 8, SJR: 0.18, h-index: 2)
Analytical Spectroscopy Library     Full-text available via subscription   (Followers: 11)
Anesthésie & Réanimation     Full-text available via subscription   (Followers: 1)
Anesthesiology Clinics     Full-text available via subscription   (Followers: 22, 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: 158, 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   (Followers: 1, 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]   [48 followers]  Follow
    
   Hybrid Journal Hybrid journal (It can contain Open Access articles)
   ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
   Published by Elsevier Homepage  [3043 journals]
  • Cumulative psychological stress and cardiovascular disease risk in middle
           aged and older women: Rationale, design, and baseline characteristics
    • Authors: Michelle A. Albert; Eva M. Durazo; Natalie Slopen; Alan M. Zaslavsky; Julie E. Buring; Ted Silva; Daniel Chasman; David R. Williams
      Pages: 1 - 12
      Abstract: Publication date: October 2017
      Source:American Heart Journal, Volume 192
      Author(s): Michelle A. Albert, Eva M. Durazo, Natalie Slopen, Alan M. Zaslavsky, Julie E. Buring, Ted Silva, Daniel Chasman, David R. Williams
      Although a growing body of evidence indicates strong links between psychological stress (stress) and untoward cardiovascular disease (CVD) outcomes, comprehensive examination of these effects remains lacking. The “Cumulative Psychological Stress and Cardiovascular Disease Risk in Middle Aged and Older Women” study is embedded within the landmark Women's Health Study (WHS) follow-up cohort and seeks to evaluate the individual and joint effects of stressors (cumulative stress) on incident CVD risk, including myocardial infarction, stroke, coronary revascularization and CVD death. GWAS data will be used for exploratory analyses to identify any genes associated with stress and CVD. This study prospectively follows 25,335 women (mean age 72.2 ± 6.04 years) without CVD who returned a short mailed stress questionnaire at baseline and 3 years of follow-up inquiring about their experiences with stress including perceived stress, work stress, work-family spillover, financial stress, traumatic and major life events, discrimination and neighborhood environment/stressors. Other domains ascertained were sleep, anger, cynical hostility, depression, anxiety, social support, intimate partner relations, and volunteer and social activities. Higher levels of cumulative stress were associated with younger age and black race/ethnicity, divorced or separated marital status, increased prevalence of obesity, smoking, diabetes, depression and anxiety (p<0.001 for each). Findings from this study will provide clinically important, new information about associations of cumulative stress, environmental, lifestyle and genetic factors with incident CVD risk in aging women.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.06.012
      Issue No: Vol. 192 (2017)
       
  • Rheumatoid arthritis complicates noninvasive whole blood gene expression
           testing for coronary artery disease
    • Authors: Ryan Jessee; Erica Peart; Phil Beineke; Steven Rosenberg; James A. Wingrove; William E. Kraus; Kim M. Huffman
      Pages: 13 - 18
      Abstract: Publication date: October 2017
      Source:American Heart Journal, Volume 192
      Author(s): Ryan Jessee, Erica Peart, Phil Beineke, Steven Rosenberg, James A. Wingrove, William E. Kraus, Kim M. Huffman
      Background Our objective was to evaluate an age- and sex-specific gene expression score (ASGES) previously validated to detect obstructive coronary artery disease (CAD) in patients with rheumatoid arthritis (RA). Methods We evaluated 20 pairs of nondiabetic coronary patients with and without RA, selected by matching on age, sex, race, body mass index, tobacco use, and number of diseased coronary vessels. Peripheral blood gene expression levels of 23 CAD-associated genes were measured, and a previously validated CAD risk score including age, sex, and gene expression levels (Corus CAD) was computed. Linear regression was used to determine effects of both CAD and RA on the ASGES. Results Among patients with RA, the ASGES was not associated with CAD. The ASGES was elevated in patients with RA (P <.04) when compared with matched controls. The presence of RA was associated with significantly altered expression for 6 of the 23 genes (P <.05 for all, not adjusted for multiple comparisons): S100 calcium binding protein A12, interleukin-18 receptor accessory protein, caspase 5, S100 calcium binding protein A8, aquaporin 9, and cluster of differentiation 79b. Conclusions Across a range of coronary artery disease severity, RA was associated with altered expression of CAD-associated genes. Notably, 2 of these genes, S100 calcium binding protein A8 and A12, are associated with neutrophil activation and are under investigation as therapeutic targets for both RA and CAD. These findings highlight common pathogenic mechanisms for RA and CAD and validate the prior exclusion of RA patients from ASGES-based evaluation of CAD likelihood.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.06.013
      Issue No: Vol. 192 (2017)
       
  • Rationale and design of the ICON-RELOADED study: International
           Collaborative of N-terminal pro–B-type Natriuretic Peptide Re-evaluation
           of Acute Diagnostic Cut-Offs in the Emergency Department
    • Authors: Hanna Kim Gaggin; Annabel Angela Chen-Tournoux; Robert H. Christenson; Gheorghe Doros; Judd Eric Hollander; Phillip David Levy; John Tobias Nagurney; Richard Michael Nowak; Peter S. Pang; Darshita Patel; Willam Frank Peacock; Elizabeth Lea Walters; James Louis Januzzi
      Pages: 26 - 37
      Abstract: Publication date: October 2017
      Source:American Heart Journal, Volume 192
      Author(s): Hanna Kim Gaggin, Annabel Angela Chen-Tournoux, Robert H. Christenson, Gheorghe Doros, Judd Eric Hollander, Phillip David Levy, John Tobias Nagurney, Richard Michael Nowak, Peter S. Pang, Darshita Patel, Willam Frank Peacock, Elizabeth Lea Walters, James Louis Januzzi
      Objectives The objectives were to reassess use of amino-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations for diagnosis and prognosis of acute heart failure (HF) in patients with acute dyspnea. Background NT-proBNP facilitates diagnosis, prognosis, and treatment in patients with suspected or proven acute HF. As demographics of such patients are changing, previous diagnostic NT-proBNP thresholds may need updating. Additionally, value of in-hospital NT-proBNP prognostic monitoring for HF is less understood. Methods In a prospective, multicenter study in the United States and Canada, patients presenting to emergency departments with acute dyspnea were enrolled, with demographic, medication, imaging, and clinical course information collected. NT-proBNP analysis will be performed using the Roche Diagnostics Elecsys proBNPII immunoassay in blood samples obtained at baseline and at discharge (if hospitalized). Primary end points include positive predictive value of previously established age-stratified NT-proBNP thresholds for the adjudicated diagnosis of acute HF and its negative predictive value to exclude acute HF. Secondary end points include sensitivity, specificity, and positive and negative likelihood ratios for acute HF and, among those with HF, the prognostic value of baseline and predischarge NT-proBNP for adjudicated clinical end points (including all-cause death and hospitalization) at 30 and 180days. Results A total of 1,461 dyspneic subjects have been enrolled and are eligible for analysis. Follow-up for clinical outcome is ongoing. Conclusions The International Collaborative of N-terminal pro–B-type Natriuretic Peptide Re-evaluation of Acute Diagnostic Cut-Offs in the Emergency Department study offers a contemporary opportunity to understand best diagnostic cutoff points for NT-proBNP in acute HF and validate in-hospital monitoring of HF using NT-proBNP.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.07.002
      Issue No: Vol. 192 (2017)
       
  • Study design and rationale for ELPIS: A phase I/IIb randomized pilot study
           of allogeneic human mesenchymal stem cell injection in patients with
           hypoplastic left heart syndrome
    • Authors: Sunjay Kaushal; Brody Wehman; Nicholas Pietris; Casey Naughton; Soren M Bentzen; Grace Bigham; Rachana Mishra; Sudhish Sharma; Luca Vricella; Allen D. Everett; Kristopher B. Deatrick; Sihong Huang; Helina Mehta; William A. Ravekes; Naru Hibino; Darcy L. Difede; Aisha Khan; Joshua M. Hare
      Pages: 48 - 56
      Abstract: Publication date: October 2017
      Source:American Heart Journal, Volume 192
      Author(s): Sunjay Kaushal, Brody Wehman, Nicholas Pietris, Casey Naughton, Soren M Bentzen, Grace Bigham, Rachana Mishra, Sudhish Sharma, Luca Vricella, Allen D. Everett, Kristopher B. Deatrick, Sihong Huang, Helina Mehta, William A. Ravekes, Naru Hibino, Darcy L. Difede, Aisha Khan, Joshua M. Hare
      Despite advances in surgical technique and postoperative care, long-term survival of children born with hypoplastic left heart syndrome (HLHS) remains limited, with cardiac transplantation as the only alternative for patients with failing single ventricle circulations. Maintenance of systemic right ventricular function is crucial for long-term survival, and interventions that improve ventricular function and avoid or defer transplantation in patients with HLHS are urgently needed. We hypothesize that the young myocardium of the HLHS patient is responsive to the biological cues delivered by bone marrow–derived mesenchymal stem cells (MSCs) to improve and preserve right ventricle function. The ELPIS trial (Allogeneic Human MEsenchymal Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome: An Open Label Pilot Study) is a phase I/IIb trial designed to test whether MSC injection will be both safe and feasible by monitoring the first 10 HLHS patients for new major adverse cardiac events. If our toxicity stopping rule is not activated, we will proceed to the phase IIb component of our study where we will test our efficacy hypothesis that MSC injection improves cardiac function compared with surgery alone. Twenty patients will be enrolled in a randomized phase II trial with a uniform allocation to MSC injection versus standard surgical care (no injection). The 2 trial arms will be compared with respect to improvement of right ventricular function, tricuspid valve annulus size, and regurgitation determined by cardiac magnetic resonance and reduced mortality, morbidity, and need for transplantation. This study will establish the safety and feasibility of allogeneic mesenchymal stem cell injection in HLHS patients and provide important insights in the emerging field of stem cell–based therapy for congenital heart disease patients.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.06.009
      Issue No: Vol. 192 (2017)
       
  • Availability of patient decision aids for stroke prevention in atrial
           fibrillation: A systematic review
    • Authors: Elizabeth S. O'Neill; Stuart W. Grande; Ariel Sherman; Glyn Elwyn; Megan Coylewright
      Pages: 1 - 11
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): Elizabeth S. O'Neill, Stuart W. Grande, Ariel Sherman, Glyn Elwyn, Megan Coylewright
      Background Atrial fibrillation is a common irregular heart rhythm that increases patients' risk of stroke. Aspirin, warfarin, direct oral anticoagulants, and an implantable device can reduce this risk. Given the availability of multiple comparable options, this decision depends on patient preferences and is appropriate for the use of decision aids and other efforts to promote shared decision making. The objective of this review was to examine the existence and accessibility of, as well as select outcomes associated with, published, formally evaluated patient decision aids for stroke prevention in atrial fibrillation. Methods Six databases were searched from inception to March 2016 with a research librarian. Two authors independently reviewed potential articles, selected trials meeting inclusion criteria, and assessed outcome measures. Outcomes included patient knowledge, involvement, choice, and decisional conflict. Results The search resulted in 666 articles; most were excluded for not examining stroke prevention in atrial fibrillation and 7 studies were eventually included. Six decision aids displayed combinations of aspirin, warfarin, or no therapy; 1 included a direct oral anticoagulant. Interventions were associated with increased patient knowledge, increased likelihood of making a choice, and low decisional conflict. Use of decision aids in this review was associated with less selection of warfarin. None of the tested decision aids are currently available. Discussion Published patient decision aids for stroke prevention in atrial fibrillation are not accessible for clinical use. Given the availability of multiple comparable options, there is a need to develop and test new patient decision aids in this context.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.05.014
      Issue No: Vol. 191 (2017)
       
  • Temporal changes in myocardial infarction incidence rates are associated
           with periods of perceived psychosocial stress: A SWEDEHEART national
           registry study
    • Authors: John Wallert; Claes Held; Guy Madison; Erik MG Olsson
      Pages: 12 - 20
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): John Wallert, Claes Held, Guy Madison, Erik MG Olsson
      Background Psychosocial stress might trigger myocardial infarction (MI). Increased MI incidence coincides with recurrent time periods during the year perceived as particularly stressful in the population. Methods A stress-triggering hypothesis on the risk of MI onset was investigated with Swedish population data on MI hospital admission date and symptom onset date (N=156,690; 148,176) as registered from 2006 through 2013 in the national quality registry database Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Poisson regression was applied to analyze daily MI rates during days belonging to the Christmas and New Year holidays, turns of the month, Mondays, weekends, and summer vacation in July compared with remaining control days. Results Adjusted incidence rate ratios (IRRs) for MI rates were higher during Christmas and New Year holidays (IRR=1.07 [1.04-1.09], P <.001) and on Mondays (IRR=1.11 [1.09-1.13], P <.001) and lower in July (IRR=0.92 [0.90-0.94], P <.001) and over weekends (IRR=0.88 [0.87-0.89], P <.001), yet not during the turns of the month (IRR=1.01 [1.00–1.02], P =.891). These findings were also predominantly robust with symptom onset as alternative outcome, when adjusting for both established and some suggested-but-untested confounders, and in 8 subgroups. Conclusions Fluctuations in daily MI incidence rates are systematically related to time periods of presumed psychosocial stress. Further research might clarify mechanisms that are amenable to clinical alteration.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.05.015
      Issue No: Vol. 191 (2017)
       
  • Sex-based differences in quality of care and outcomes in a health system
           using a standardized STEMI protocol
    • Authors: Janet Wei; Puja K. Mehta; Elizabeth Grey; Ross F. Garberich; Robert Hauser; C. Noel Bairey Merz; Timothy D. Henry
      Pages: 30 - 36
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): Janet Wei, Puja K. Mehta, Elizabeth Grey, Ross F. Garberich, Robert Hauser, C. Noel Bairey Merz, Timothy D. Henry
      Background Recent data from the National Cardiovascular Data Registry indicate that women with ST-segment-elevation myocardial infarction (STEMI) continue to have higher mortality and reported delays in treatment compared with men. We aimed to determine whether the sex difference in mortality exists when treatment disparities are reduced. Methods Using a prospective regional percutaneous coronary intervention (PCI)–based STEMI system database with a standardized STEMI protocol, we evaluated baseline characteristics, treatment, and clinical outcomes of STEMI patients stratified by sex. Results From March 2003 to January 2016, 4,918 consecutive STEMI patients presented to the Minneapolis Heart Institute at Abbott Northwestern Hospital regional STEMI system including 1,416 (28.8%) women. Compared with men, women were older (68.4 vs 60.9 years) with higher rates of hypertension (66.7% vs 55.7%), diabetes (21.7% vs 17.4%), and cardiogenic shock (11.5% vs 8.0%) (all P < .001). Pre-revascularization medications and PCI were performed with same frequencies, but women were less likely to receive statin or antiplatelet therapy at discharge. After age adjustment, women had similar in-hospital mortality to men (5.1% vs 4.8%, P = .60) despite slightly longer door-to-balloon time (95 vs 92 minutes, P = .004). Five-year follow-up confirmed absence of a sex disparity in age-adjusted survival post-STEMI. Conclusions Previously reported treatment disparities between men and women are diminished in a regional PCI-based STEMI system using a standardized STEMI protocol. No sex differences in short-term or long-term age-adjusted mortality are present in this registry despite some treatment disparities. These results suggest that STEMI health care disparities and mortality in women can be improved using STEMI protocols and systems.

      PubDate: 2017-07-12T16:44:13Z
      DOI: 10.1016/j.ahj.2017.06.005
      Issue No: Vol. 191 (2017)
       
  • A randomized, multicenter, open-label, blinded end point trial comparing
           the effects of spironolactone to chlorthalidone on left ventricular mass
           in patients with early-stage chronic kidney disease: Rationale and design
           of the SPIRO-CKD trial
    • Authors: Manvir K. Hayer; Nicola C. Edwards; Gemma Slinn; William E. Moody; Rick P. Steeds; Charles J. Ferro; Anna M. Price; Cecilio Andujar; Mary Dutton; Rachel Webster; David J. Webb; Scott Semple; Iain MacIntyre; Vanessa Melville; Ian B. Wilkinson; Thomas F. Hiemstra; David C. Wheeler; Anna Herrey; Margaret Grant; Samir Mehta; Natalie Ives; Jonathan N. Townend
      Pages: 37 - 46
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): Manvir K. Hayer, Nicola C. Edwards, Gemma Slinn, William E. Moody, Rick P. Steeds, Charles J. Ferro, Anna M. Price, Cecilio Andujar, Mary Dutton, Rachel Webster, David J. Webb, Scott Semple, Iain MacIntyre, Vanessa Melville, Ian B. Wilkinson, Thomas F. Hiemstra, David C. Wheeler, Anna Herrey, Margaret Grant, Samir Mehta, Natalie Ives, Jonathan N. Townend
      Background Chronic kidney disease (CKD) is associated with increased left ventricular (LV) mass and arterial stiffness. In a previous trial, spironolactone improved these end points compared with placebo in subjects with early-stage CKD, but it is not known whether these effects were specific to the drug or secondary to blood pressure lowering. Aim The aim was to investigate the hypothesis that spironolactone is superior to chlorthalidone in the reduction of LV mass while exerting similar effects on blood pressure. Design This is a multicenter, prospective, randomized, open-label, blinded end point clinical trial initially designed to compare the effects of 40weeks of treatment with spironolactone 25mg once daily to chlorthalidone 25mg once daily on the co-primary end points of change in pulse wave velocity and change in LV mass in 350 patients with stages 2 and 3 CKD on established treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Because of slow recruitment rates, it became apparent that it would not be possible to recruit this sample size within the funded time period. The study design was therefore changed to one with a single primary end point of LV mass requiring 150 patients. Recruitment was completed on 31 December 2016, at which time 154 patients had been recruited. Investigations included cardiac magnetic resonance imaging, applanation tonometry, 24-hour ambulatory blood pressure monitoring, and laboratory tests. Subjects are assessed before and after 40weeks of randomly allocated drug therapy and at 46weeks after discontinuation of the study drug.

      PubDate: 2017-07-12T16:44:13Z
      DOI: 10.1016/j.ahj.2017.05.008
      Issue No: Vol. 191 (2017)
       
  • Depression is associated with recurrent chest pain with or without
           coronary artery disease: A prospective cohort study in the emergency
           department
    • Authors: Yeunjung Kim; Morgan Soffler; Summer Paradise; Qurat-ul-ain Jelani; James Dziura; Rajita Sinha; Basmah Safdar
      Pages: 47 - 54
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): Yeunjung Kim, Morgan Soffler, Summer Paradise, Qurat-ul-ain Jelani, James Dziura, Rajita Sinha, Basmah Safdar
      Only a small fraction of acute chest pain in the emergency department (ED) is due to obstructive coronary artery disease (CAD). ED chest pain remains associated with high rates of recidivism, often in the presence of nonobstructive CAD. Psychological states such as depression, anxiety, and elevation of perceived stress may account for this finding. The objective of the study was to determine whether psychological states predict recurrent chest pain (RCP). Methods We conducted a prospective cohort study of low– to moderate–cardiac risk ED patients admitted to the Yale Chest Pain Center with acute chest pain. Depression, anxiety, and perceived stress were assessed in each patient using multistudy-validated screening scales: Patient Health Questionnaire (PHQ8), Clinical Anxiety Scale (CAS), and Perceived Stress Scale (PSS), respectively. All patients ruled out for infarction underwent appropriate cardiac stress testing. Primary outcome was RCP at 30 days evaluated by phone follow-up and medical record. The relationship between each psychological scale and RCP was evaluated using ordinal logistic regressions, controlling for known sociodemographic and cardiac risk factors. Depression (PHQ8≥10), anxiety (CAS≥30), and perceived stress (PSS≥15) were considered positive. Results Between August 2013 and May 2015, 985 patients were screened at the Yale Chest Pain Center. Of 500 enrolled patients, 483 patients had complete data and 365 (76%) patients completed follow-up. Thirty-six percent (n=131) had RCP within 1 month. On multivariable regression models, depression (odds ratio [OR]=2.11, 95% CI 1.18-3.79) was a significant independent predictor of 30-day chest pain recurrence after adjustment, whereas PSS (OR=0.96, 95% CI 0.60-1.53) and anxiety (OR=1.59, 95% CI 0.80-3.20) were not. Similarly, there was a direct relationship between psychometric evaluation of depression (via PHQ8) and the frequency of chest pain. Conclusions Depression is independently associated with RCP regardless of significant cardiac ischemia on stress testing. Identification and targeted interventions may curtail recidivism with RCP.

      PubDate: 2017-07-23T17:04:04Z
      DOI: 10.1016/j.ahj.2017.06.003
      Issue No: Vol. 191 (2017)
       
  • Soluble endothelial cell-selective adhesion molecule and incident
           cardiovascular events in a multiethnic population
    • Authors: Hao-Yu Ren; Amit Khera; James A. de Lemos; Colby R. Ayers; Anand Rohatgi
      Pages: 55 - 61
      Abstract: Publication date: September 2017
      Source:American Heart Journal, Volume 191
      Author(s): Hao-Yu Ren, Amit Khera, James A. de Lemos, Colby R. Ayers, Anand Rohatgi
      Background Cell adhesion molecules are key regulators of atherosclerotic plaque development, but circulating levels of soluble fragments, such as intercellular adhesion molecule (sICAM-1) and vascular cell adhesion molecule (sVCAM-1), have yielded conflicting associations with atherosclerotic cardiovascular disease (ASCVD). Endothelial cell-selective adhesion molecule (ESAM) is expressed exclusively in platelets and endothelial cells, and soluble ESAM (sESAM) levels have been associated with prevalent subclinical atherosclerosis. We therefore hypothesized that sESAM would be associated with incident ASCVD. Methods sESAM, sICAM-1, and sVCAM-1 were measured in 2,442 participants without CVD in the Dallas Heart Study, a probability-based population sample aged 30-65 years enrolled between 2000 and 2002. ASCVD was defined as first myocardial infarction, stroke, coronary revascularization, or CV death. A total of 162 ASCVD events were analyzed over 10.4 years. Results Increasing sESAM was associated with ASCVD, independent of risk factors (HR Q4 vs Q1: 2.7, 95% CI 1.6-4.6). Serial adjustment for renal function, sICAM-1, VCAM-1, and prevalent coronary calcium did not attenuate these associations. Continuous ESAM demonstrated similar findings (HR 1.31, 95% CI 1.2-1.4). Addition of sESAM to traditional risk factors improved discrimination and reclassification (delta c-index: P = .009; integrated-discrimination-improvement index P = .001; net reclassification index = 0.42, 95% CI 0.15-0.68). Neither sICAM-1 nor sVCAM-1 was independently associated with ASCVD. Conclusions sESAM but not sICAM-1 or sVCAM-1 levels are associated with incident ASCVD. Further studies are warranted to investigate the role of sESAM in ASCVD.

      PubDate: 2017-07-23T17:04:04Z
      DOI: 10.1016/j.ahj.2017.06.008
      Issue No: Vol. 191 (2017)
       
  • High-sensitivity C-reactive protein is an independent marker of abnormal
           coronary vasoreactivity in patients with non-obstructive coronary artery
           disease
    • Authors: Jaskanwal D.S. Sara; Megha Prasad; Ming Zhang; Ryan J. Lennon; Joerg Herrmann; Lilach O. Lerman; Amir Lerman
      Pages: 1 - 11
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Jaskanwal D.S. Sara, Megha Prasad, Ming Zhang, Ryan J. Lennon, Joerg Herrmann, Lilach O. Lerman, Amir Lerman
      Background Coronary endothelial dysfunction (CED) is an early stage of atherosclerosis and is associated with adverse cardiovascular events. Inflammation may play a role in the development of endothelial dysfunction. To date no study has evaluated the relationship between C-reactive protein and CED. We aimed to determine if C-reactive protein is associated with CED. Methods In 1016 patients (mean age 50.7±12.3 years, 34% male) presenting to the catheterization laboratory with chest pain and non-obstructive coronary artery disease, coronary vasoreactivity was assessed by measuring the percent change in coronary blood flow (%ΔCBF) and coronary artery diameter (%ΔCAD) in response to intracoronary acetylcholine. Plasma high sensitivity C-reactive protein (hs-CRP) was measured and patients were divided into 2 groups: hs-CRP≤3.0 mg/L (low-intermediate cardiovascular risk n=169) and 3 mg/L<hs-CRP≤10 mg/L (high cardiovascular risk n=847). Results Patients with a high risk hs-CRP had a significantly lower %ΔCBF and %ΔCAD in response to acetylcholine vs low risk hs-CRP (43.8±6.1 vs 65.8±4.5, P =.004 and −17.2±1.5 vs −13.1±0.8, P =.02 respectively). Low risk hs-CRP was associated with significantly higher %ΔCBF and %ΔCAD vs high risk hs-CRP (27.1±11.0, P =.01 and 4.5±1.9, P =.02 respectively). CED was associated with significantly higher hs-CRP levels and high risk hs-CRP was independently associated with abnormal coronary vasoreactivity, OR 1.82 (95% CI 1.25–2.69). Conclusions Hs-CRP is independently associated with and a strong predictor of abnormal coronary vasoreactivity in patients with non-obstructive coronary artery disease.

      PubDate: 2017-05-24T14:33:48Z
      DOI: 10.1016/j.ahj.2017.02.035
      Issue No: Vol. 190 (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
      Pages: 19 - 24
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      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-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 10 days) 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 ≥12 months and up to 3 years. Outcomes The primary objective is to compare the incidence rate of detected AF through 12 months 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: 2017-05-29T14:44:30Z
      DOI: 10.1016/j.ahj.2017.04.007
      Issue No: Vol. 190 (2017)
       
  • Implantable cardiac monitors in high-risk post-infarction patients with
           cardiac autonomic dysfunction and moderately reduced left ventricular
           ejection fraction: Design and rationale of the SMART-MI trial
    • Authors: Wolfgang Hamm; Konstantinos D. Rizas; Lukas von Stülpnagel; Nikolay Vdovin; Steffen Massberg; Stefan Kääb; Axel Bauer
      Pages: 34 - 39
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Wolfgang Hamm, Konstantinos D. Rizas, Lukas von Stülpnagel, Nikolay Vdovin, Steffen Massberg, Stefan Kääb, Axel Bauer
      Background Most deaths after myocardial infarction (MI) occur in patients with left ventricular ejection fraction (LVEF) >35%, for whom no specific prophylactic strategies exist. Deceleration capacity (DC) of heart rate and periodic repolarization dynamics (PRD) are noninvasive electrophysiological markers depending on the vagal and sympathetic tone. The combination of abnormal DC and/or PRD identifies a new high-risk group among postinfarction patients with LVEF 36%-50%. This new high-risk group has similar characteristics with respect to prognosis and patient numbers to those of the established high-risk group identified by LVEF ≤ 35%. Study design The SMART-MI trial is an investigator-initiated randomized prospective multicenter trial that tests the efficacy of implantable cardiac monitors (ICM) in this new high-risk group. The study will enroll approximately 1,600 survivors of acute MI with sinus rhythm and an LVEF of 35%-50% in 17 centers in Germany who will be tested for presence of cardiac autonomic dysfunction. Four hundred patients with either abnormal DC (≤2.5 ms) and/or PRD (≥5.75deg2) will be randomized in a 1:1 fashion to intensive follow-up via telemonitoring using an ICM device (experimental arm) or conventional follow-up (control arm). For the ICM arm, specific treatment paths have been developed according to current guidelines. Outcomes The primary end point is time to detection of predefined serious arrhythmic events during follow-up, including atrial fibrillation ≥6minutes, nonsustained ventricular tachycardia (cycle length≤320 ms; ≥40 beats), atrioventricular block ≥IIb, and sustained ventricular tachycardia/ventricular fibrillation. The median follow-up period is 18months with a minimum follow-up of 6months. The effect of remote monitoring on clinical outcomes will be tested as secondary outcome measure (ClinicalTrials.gov NCT02594488).

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.006
      Issue No: Vol. 190 (2017)
       
  • Brain-derived neurotrophic factor rs6265 (Val66Met) polymorphism is
           associated with disease severity and incidence of cardiovascular events in
           a patient cohort
    • Authors: Rong Jiang; Michael A. Babyak; Beverly H. Brummett; Elizabeth R. Hauser; Svati H. Shah; Richard C. Becker; Ilene C. Siegler; Abanish Singh; Carol Haynes; Megan Chryst-Ladd; Damian M. Craig; Redford B. Williams
      Pages: 40 - 45
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Rong Jiang, Michael A. Babyak, Beverly H. Brummett, Elizabeth R. Hauser, Svati H. Shah, Richard C. Becker, Ilene C. Siegler, Abanish Singh, Carol Haynes, Megan Chryst-Ladd, Damian M. Craig, Redford B. Williams
      Background The rs6265 (Val66Met) single-nucleotide polymorphism in the BDNF gene has been related to a number of endophenotypes that have in turn been shown to confer risk for atherosclerotic cardiovascular disease (CVD). To date, however, very few studies have examined the association of the Val66Met single-nucleotide polymorphism with CVD clinical outcomes. Methods In a cohort of 5,510 Caucasian patients enrolled in the CATHeterization GENetics (CATHGEN) study at Duke University Hospital between 2001 and 2011, we determined the severity of coronary artery disease (CAD) and CVD event incidence through up to 11.8years of follow-up. We examined the association of Val66Met genotype with time-to-death or myocardial infarction, adjusting for age, sex, CAD risk variables, and CAD severity measures. Results The Val/Val genotype was associated with a higher risk than Met carriers for clinical CVD events (P =.034, hazard ratio 1.12, 95% CI 1.01-1.24). In addition, compared with Met carriers, individuals with the Val/Val genotype had a greater odds of having more diseased vessels (odds ratio 1.17, 95% CI 1.06-1.30, P =.002), and lower left ventricular ejection fraction (β=−0.72, 95% CI, −1.42 to −0.02, P =.044). Conclusions The Val/Val genotype was associated with greater severity of CAD and incidence of CVD-related clinical events in a patient sample. If these findings are confirmed in further research, intervention studies in clinical groups with the Val/Val genotype could be undertaken to prevent disease and improve prognosis.

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.002
      Issue No: Vol. 190 (2017)
       
  • Retained cardiac implantable electronic device fragments are not
           associated with magnetic resonance imaging safety issues, morbidity, or
           mortality after orthotopic heart transplant
    • Authors: Christopher O. Austin; Kevin Landolfo; Pragnesh P. Parikh; Parag C. Patel; K.L. Venkatachalam; Fred M. Kusumoto
      Pages: 46 - 53
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Christopher O. Austin, Kevin Landolfo, Pragnesh P. Parikh, Parag C. Patel, K.L. Venkatachalam, Fred M. Kusumoto
      Background Cardiac implantable electronic device therapy (CIED) has revolutionized treatment for advanced heart failure. Most patients considered for orthotopic heart transplantation (OHT) are treated with implantable cardioverter defibrillators, cardiac resynchronization therapy, or both. These CIEDs are surgically extracted at the time of transplant. Occasionally, CIEDs are incompletely removed. Little is known about the outcomes of post-OHT patients with retained CIED fragments. Methods We identified 200 consecutive patients that underwent OHT at our institution between April 2006 and December 2014 and performed a retrospective analysis of available radiographic images and clinical records. Chest radiographs prior to and following OHT were reviewed for the presence of CIED or retained CIED fragments. The outcomes of patients with retained CIED fragments that had subsequent magnetic resonance imaging (MRI) studies performed were further investigated. Results One hundred eighty of 200 patients were identified as having CIED prior to OHT, of which 29 had retained CIED fragments after OHT. Most retained CIED fragments originated from superior vena cava defibrillator coils. There were no adverse events in the retained CIED fragment cohort, and survival was unaffected. Ten patients with retained CIED fragments safely underwent a total of 28 MRIs after OHT, all of diagnostic quality. Conclusion Retained CIED fragments are not associated with adverse events or increased mortality after OHT. Diagnostic MRI has been safely performed in patients with retained CIED fragments after incomplete device extraction. Retrieval of these fragments prior to MRI does not appear warranted given the demonstrated safety and preserved image quality in this population.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.04.011
      Issue No: Vol. 190 (2017)
       
  • Clinical outcomes with percutaneous coronary revascularization vs coronary
           artery bypass grafting surgery in patients with unprotected left main
           coronary artery disease: A meta-analysis of 6 randomized trials and 4,686
           patients
    • Authors: Tullio Palmerini; Patrick Serruys; Arie Pieter Kappetein; Philippe Genereux; Diego Della Riva; Letizia Bacchi Reggiani; Evald Christiansen; Niels R. Holm; Leif Thuesen; Timo Makikallio; Marie Claude Morice; Jung-Min Ahn; Seung-Jung Park; Holger Thiele; Enno Boudriot; Mario Sabatino; Mattia Romanello; Giuseppe Biondi-Zoccai; Raphael Cavalcante; Joseph F. Sabik; Gregg W. Stone
      Pages: 54 - 63
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Tullio Palmerini, Patrick Serruys, Arie Pieter Kappetein, Philippe Genereux, Diego Della Riva, Letizia Bacchi Reggiani, Evald Christiansen, Niels R. Holm, Leif Thuesen, Timo Makikallio, Marie Claude Morice, Jung-Min Ahn, Seung-Jung Park, Holger Thiele, Enno Boudriot, Mario Sabatino, Mattia Romanello, Giuseppe Biondi-Zoccai, Raphael Cavalcante, Joseph F. Sabik, Gregg W. Stone
      Some but not all randomized controlled trials (RCT) have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative to coronary artery bypass grafting (CABG) surgery for the treatment of unprotected left main coronary artery disease (ULMCAD). We therefore aimed to compare the risk of all-cause mortality between PCI and CABG in patients with ULMCAD in a pairwise meta-analysis of RCT. Methods Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Results Six trials including 4,686 randomized patients were identified. After a median follow-up of 39 months, there were no significant differences between PCI vs CABG in the risk of all-cause mortality (hazard ratio [HR] 0.99, 95% CI 0.76-1.30) or cardiac mortality. However, a significant interaction for cardiac mortality (P interaction= .03) was apparent between randomization arm and SYNTAX score, such that the relative risk for mortality tended to be lower with PCI compared with CABG among patients in the lower SYNTAX score tertile, similar in the intermediate tertile, and higher in the upper SYNTAX score tertile. Percutaneous coronary intervention compared with CABG was associated with a similar long-term composite risk of death, myocardial infarction, or stroke (HR 1.06, 95% CI 0.82-1.37), with fewer events within 30 days after PCI offset by fewer events after 30 days with CABG (P interaction < .0001). Percutaneous coronary intervention was associated with greater rates of unplanned revascularization compared with CABG (HR 1.74, 95% CI 1.47-2.07). Conclusions In patients undergoing revascularization for ULMCAD, PCI was associated with similar rates of mortality compared with CABG at a median follow-up of 39 months, but with an interaction effect suggesting relatively lower mortality with PCI in patients with low SYNTAX score and relatively lower mortality with CABG in patients with high SYNTAX score. Both procedures resulted in similar long-term composite rates of death, myocardial infarction, or stroke, with PCI offering an early safety advantage and CABG demonstrating greater durability.

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.005
      Issue No: Vol. 190 (2017)
       
  • Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular
           events (ISLAND): Pragmatic randomized trial protocol
    • Authors: Noah Ivers; J-D Schwalm; Holly O. Witteman; Justin Presseau; Monica Taljaard; Tara McCready; Beth Bosiak; Jennifer Cunningham; Shelley Smarz; Laura Desveaux; Jack V. Tu; Clare Atzema; Garth Oakes; Wanrudee Isaranuwatchai; Sherry L. Grace; R. Sacha Bhatia; Madhu Natarajan; Jeremy M. Grimshaw
      Pages: 64 - 75
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Noah Ivers, J-D Schwalm, Holly O. Witteman, Justin Presseau, Monica Taljaard, Tara McCready, Beth Bosiak, Jennifer Cunningham, Shelley Smarz, Laura Desveaux, Jack V. Tu, Clare Atzema, Garth Oakes, Wanrudee Isaranuwatchai, Sherry L. Grace, R. Sacha Bhatia, Madhu Natarajan, Jeremy M. Grimshaw
      Background Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. Methods This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. Conclusions We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions.

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.007
      Issue No: Vol. 190 (2017)
       
  • Use of endpoint adjudication to improve the quality and validity of
           endpoint assessment for medical device development and post marketing
           evaluation: Rationale and best practices. A report from the cardiac safety
           research consortium
    • Authors: Jonathan H Seltzer; Ted Heise; Peter Carson; Daniel Canos; Jo Carol Hiatt; Pascal Vranckx; Thomas Christen; Donald E Cutlip
      Pages: 76 - 85
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Jonathan H Seltzer, Ted Heise, Peter Carson, Daniel Canos, Jo Carol Hiatt, Pascal Vranckx, Thomas Christen, Donald E Cutlip
      This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”. The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.05.009
      Issue No: Vol. 190 (2017)
       
  • County socioeconomic characteristics and heart transplant outcomes in the
           United States
    • Authors: Dmitry Tumin; Jessica Horan; Emily A. Shrider; Sakima A. Smith; Joseph D. Tobias; Don Hayes; Randi E. Foraker
      Pages: 104 - 112
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Dmitry Tumin, Jessica Horan, Emily A. Shrider, Sakima A. Smith, Joseph D. Tobias, Don Hayes, Randi E. Foraker
      Background Geographic disparities in survival after heart transplantation have received mixed support in prior studies, and specific geographic characteristics that might be responsible for these differences are unclear. We tested for differences in heart transplant outcomes across United States (US) counties after adjustment for individual-level covariates. Our secondary aim was to evaluate whether specific county-level socioeconomic characteristics explained geographic disparities in survival. Methods Data on patients aged ≥18 years undergoing a first-time heart transplant between July 2006 and December 2014 were obtained from the United Network for Organ Sharing. Residents of counties represented by <5 patients were excluded. Patient survival (censored in March 2016) was analyzed using multivariable Cox regression. Shared frailty models were used to test for residual differences in overall all-cause mortality across counties after adjusting for recipient and donor characteristics. Measures of county economic disadvantage, inequality, and racial segregation were obtained from US Census data and coded into quintiles. A likelihood ratio test determined whether adjusting for each county measure improved the fit of the Cox model. Results Multivariable analysis of 10,879 heart transplant recipients found that, adjusting for individual-level characteristics, there remained statistically significant variation in mortality hazard across US counties (P =.004). Adjusting for quintiles of community disadvantage, economic inequality, or racial segregation did not significantly improve model fit (likelihood ratio test P =.092, P =.273, and P =.107, respectively) and did not explain residual differences in patient survival across counties. Conclusions Heart transplantation outcomes vary by county, but this difference is not attributable to county-level socioeconomic disadvantage.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.05.013
      Issue No: Vol. 190 (2017)
       
  • Effects of serelaxin on the outcome of patients with or without
           substantial peripheral edema: A subgroup analysis from the RELAX-AHF trial
           
    • Authors: Claudio Gimpelewicz; Marco Metra; John G.F Cleland; Peter Szecsödy; Chuan-Chuan Chang Wun; Leandro Boer-Martins; Gad Cotter; Beth A. Davison; Gary Michael Felker; Gerasimos Filippatos; Barry H. Greenberg; Peter Pang; Piotr Ponikowski; Thomas Severin; Adrian A. Voors; John R. Teerlink
      Pages: 113 - 122
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Claudio Gimpelewicz, Marco Metra, John G.F Cleland, Peter Szecsödy, Chuan-Chuan Chang Wun, Leandro Boer-Martins, Gad Cotter, Beth A. Davison, Gary Michael Felker, Gerasimos Filippatos, Barry H. Greenberg, Peter Pang, Piotr Ponikowski, Thomas Severin, Adrian A. Voors, John R. Teerlink
      Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5%) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5%). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.

      PubDate: 2017-06-18T16:55:11Z
      DOI: 10.1016/j.ahj.2017.05.012
      Issue No: Vol. 190 (2017)
       
  • Prevention of sudden cardiac death in the young: Developing a rational,
           reliable, and sustainable national health care resource. A report from the
           Cardiac Safety Research Consortium
    • Authors: Salim F. Idriss; Stuart Berger; Kimberly G. Harmon; Allen Kindman; Robert Kleiman; Martha Lopez-Anderson; Silvana Molossi; Tess (Elizabeth) Saarel; Colette Strnadova; Thomas Todaro; Kaori Shinagawa; Valarie Morrow; Mitchell Krucoff; Victoria Vetter; Theressa J. Wright
      Pages: 123 - 131
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Salim F. Idriss, Stuart Berger, Kimberly G. Harmon, Allen Kindman, Robert Kleiman, Martha Lopez-Anderson, Silvana Molossi, Tess (Elizabeth) Saarel, Colette Strnadova, Thomas Todaro, Kaori Shinagawa, Valarie Morrow, Mitchell Krucoff, Victoria Vetter, Theressa J. Wright
      This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses important issues regarding sudden cardiac death in the young (SCDY), a problem that does not discriminate by gender, race, ethnicity, education, socioeconomic level, or athletic status. The occurrence of SCDY has devastating impact on families and communities. Sudden cardiac death in the young is a matter of national and international public health, and its prevention has generated deep interest from multiple stakeholders, including families who have lost children, advocacy groups, academicians, regulators, and the medical industry. To promote scientific and clinical discussion of SCDY prevention and to germinate future initiatives to move this field forward, a Cardiac Safety Research Consortium–sponsored Think Tank was held on February 21, 2015 at the US Food and Drug Administration's White Oak facilities, Silver Spring, MD. The ultimate goal of the Think Tank was to spark initiatives that lead to the development of a rational, reliable, and sustainable national health care resource focused on SCDY prevention. This article provides a detailed summary of discussions at the Think Tank and descriptions of related multistakeholder initiatives now underway: it does not represent regulatory guidance.

      PubDate: 2017-07-03T23:29:15Z
      DOI: 10.1016/j.ahj.2017.05.003
      Issue No: Vol. 190 (2017)
       
  • The troponin decision-point dilemma: The 99th percentile solution “do
           the best you can [with cardiac troponin] until you know better. Then when
           you know better, do better.” Maya Angelou, poet, dancer, producer,
           playwright, director, author
    • Authors: Robert H. Christenson; Christopher R. deFilippi
      Pages: 132 - 134
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Robert H. Christenson, Christopher R. deFilippi


      PubDate: 2017-07-30T17:25:43Z
      DOI: 10.1016/j.ahj.2017.06.004
      Issue No: Vol. 190 (2017)
       
  • Predictors of high cost after percutaneous coronary intervention: A review
           from Japanese multicenter registry overviewing the influence of procedural
           complications
    • Authors: Taku Inohara; Yohei Numasawa; Takahiro Higashi; Ikuko Ueda; Masahiro Suzuki; Kentaro Hayashida; Shinsuke Yuasa; Yuichiro Maekawa; Keiichi Fukuda; Shun Kohsaka
      Abstract: Publication date: Available online 18 August 2017
      Source:American Heart Journal
      Author(s): Taku Inohara, Yohei Numasawa, Takahiro Higashi, Ikuko Ueda, Masahiro Suzuki, Kentaro Hayashida, Shinsuke Yuasa, Yuichiro Maekawa, Keiichi Fukuda, Shun Kohsaka
      Background Percutaneous coronary intervention (PCI) is widely used; however, factors of high-cost care after PCI have not been thoroughly investigated. We sought to evaluate the in-hospital costs related to PCI and identify predictors of high costs. Methods We extracted 2354 consecutive PCI cases (1243 acute cases, 52.8%) from three Japanese cardiovascular centers from 2011 to 2015. In-hospital complications were pre-defined under consensus definitions (e.g., acute kidney injury [AKI]). We extracted the facility cost data for each patient's resource under the universal Japanese insurance system. We classified the patients into total cost quartiles and identified predictors for the highest quartile (“High-cost” group). In addition, incremental costs for procedure-related complications were calculated. Results During the study period, a total of 401 cases (17.0%) experienced procedure-related complications. The in-hospital acute and elective PCI costs per case were 14,840 USD (Interquartile range [IQR]: 11,370, 20,070) and 11,030 USD (IQR: 8929, 14,670), respectively. After adjusting for baseline differences, any of the procedure-related complications remained an independent predictor of high costs (acute: odds ratio [OR], 1.66; 95% confidence intervals [CIs], 1.13–2.43; elective: OR, 3.73; 95% CIs, 1.96–7.11). Notably, incremental costs were mainly attributed to AKI, which accounted for 37.5% of all incremental costs; it increased by 9840 USD for each AKI event, and the total cost increase attained 2,588,035 USD. Conclusions Procedure-related complications, particularly post-procedural AKI, were associated with higher costs in PCI. Further studies are required to evaluate prospectively whether the preventive strategy with a personalized risk stratification for AKI could save costs.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.008
       
  • Outcomes in elderly and young patients with ST-segment elevation
           myocardial infarction undergoing primary percutaneous coronary
           intervention with bivalirudin versus heparin: pooled analysis from the
           EUROMAX and HORIZONS-AMI trials
    • Authors: Khalid Qaderdan; Gerrit-Jan A. Vos; Thomas McAndrew; Philippe Gabriel Steg; Christian W. Hamm; Arnoud van't Hof; Roxana Mehran; Efthymios N. Deliargyris; Debra Bernstein; Gregg W. Stone; Jurriën M. ten Berg
      Abstract: Publication date: Available online 18 August 2017
      Source:American Heart Journal
      Author(s): Khalid Qaderdan, Gerrit-Jan A. Vos, Thomas McAndrew, Philippe Gabriel Steg, Christian W. Hamm, Arnoud van't Hof, Roxana Mehran, Efthymios N. Deliargyris, Debra Bernstein, Gregg W. Stone, Jurriën M. ten Berg
      Since older age is a strong predictor of not only bleeding but also of ischemic events, understanding the risk:benefit profile of bivalirudin in the elderly undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation (STEMI) is important. For this, we aim to compare elderly with young patients, who all underwent pPCI for STEMI and randomly received either bivalirudin or heparin. Methods We performed a patient-level pooled analysis (n=5800) of two large randomized trials. A total of 2149 (37.1%) elderly patients (>65years of age) with STEMI were enrolled and randomly assigned to either bivalirudin or heparin with or without a GPI (control group) before pPCI. Clinical outcomes at 30days were analysed. Results In elderly patients, bivalirudin significantly reduced non-CABG major bleeding (7.1% vs. 10.4%; P <.01), subacute ST (0.4% vs. 1.5%; P <.01), and net adverse clinical events (NACE; composite of all-cause mortality, reinfarction, IDR, stroke or protocol-defined non-CABG major bleeding [13.7% vs 17.2%; P =.03]) with comparable rates of stroke, MI, acute ST, or all-cause death, when compared with heparin with or without GPI. Conclusions In a large group of elderly patients enrolled in the EUROMAX and HORIZONS-AMI trials, bivalirudin was associated with lower 30-day rates of non-CABG major bleeding, subacute ST and NACE, with similar 30-day rates of acute ST and mortality.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.009
       
  • Idarucizumab Since FDA Approval: Use in the Real-World
    • Authors: Joseph Ebinger; Christopher B. Granger; Alexander Zhu; Allison Chang; Timothy D. Henry
      Abstract: Publication date: Available online 15 August 2017
      Source:American Heart Journal
      Author(s): Joseph Ebinger, Christopher B. Granger, Alexander Zhu, Allison Chang, Timothy D. Henry


      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.007
       
  • Durability of Quality of Life Benefits of Transcatheter Aortic Valve
           Replacement: Long-Term Results from the CoreValve US Extreme Risk Trial
    • Authors: Suzanne J. Baron; Suzanne V. Arnold; Matthew R. Reynolds; Kaijun Wang; Michael Deeb; Michael J. Reardon; James Hermiller; Steven J. Yakubov; David H. Adams; Jeffrey J. Popma; David J. Cohen
      Abstract: Publication date: Available online 12 August 2017
      Source:American Heart Journal
      Author(s): Suzanne J. Baron, Suzanne V. Arnold, Matthew R. Reynolds, Kaijun Wang, Michael Deeb, Michael J. Reardon, James Hermiller, Steven J. Yakubov, David H. Adams, Jeffrey J. Popma, David J. Cohen
      Background For patients with severe aortic stenosis (AS) at extreme surgical risk, transcatheter aortic valve replacement (TAVR) leads to improved survival and health status when compared with medical therapy. Whether the early health status benefits of TAVR in these patients are sustained beyond 1year of follow-up is unknown. Methods and Results 639 patients with severe AS at extreme surgical risk underwent TAVR in the CoreValve US Extreme Risk Pivotal trial. Health status was evaluated at baseline and at 1, 6, 12, 24, and 36months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short-Form-12, and the EuroQoL-5D. Analyses were performed using pattern mixture models to account for both death and missing data and were stratified by iliofemoral (IF) and non-iliofemoral (non-IF) access. After TAVR, there was substantial health status improvement in disease-specific and generic scales by 6–12months. Although there were small declines in health status after 12months, the initial benefits of TAVR were largely sustained through 3years for both IF and non-IF cohorts (change from baseline in KCCQ Overall Summary score 19.0 points in IF patients and 14.9 points in non-IF patients; P <.01 for both comparisons). Among surviving patients, clinically meaningful (≥10 point) improvements in the KCCQ Overall Summary Score at 3years were observed in 85.0% and 83.4% of IF and non-IF patients respectively. Conclusions Among extreme risk patients with severe AS, TAVR resulted in large initial health status benefits that were sustained through 3-year follow-up. Although late mortality was high in this population, these findings demonstrate that TAVR offers substantial and durable health status improvements for surviving patients.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.006
       
  • Lipid Management in Contemporary Community Practice: Results from the
           Provider Assessment of Lipid Management (PALM) Registry
    • Authors: Ann Marie Navar; Tracy Y. Wang; Shuang Li; Jennifer G. Robinson; Anne C. Goldberg; Salim Virani; Veronique L. Roger; Peter W.F. Wilson; Joseph Elassal; L. Veronica Lee; Eric D. Peterson
      Abstract: Publication date: Available online 12 August 2017
      Source:American Heart Journal
      Author(s): Ann Marie Navar, Tracy Y. Wang, Shuang Li, Jennifer G. Robinson, Anne C. Goldberg, Salim Virani, Veronique L. Roger, Peter W.F. Wilson, Joseph Elassal, L. Veronica Lee, Eric D. Peterson
      Background The latest cholesterol guidelines have shifted focus from achieving low-density lipoprotein cholesterol (LDL-C) targets towards statin use and intensity guided by atherosclerotic cardiovascular disease (ASCVD) risk. Methods Statin use and intensity were evaluated in 5905 statin-eligible primary or secondary prevention patients from 138 PALM Registry practices. Results Overall, 74.7% of eligible adults were on statins; only 42.4% were on guideline-recommended intensity. Relative to primary prevention patients, ASCVD patients were more likely to be on a statin (83.6% vs. 63.4%, P <.0001) and guideline-recommended intensity (47.3% vs. 36.0%, P <.0001). Men were more likely than women to be prescribed recommended intensity for primary (OR 1.87, 95% CI 1.49–2.34) and secondary (OR 1.47, 95% CI 1.26–1.70) prevention. In primary prevention, increasing age, diabetes, obesity, hypertension, and lower 10-year ASCVD risk were associated with increased odds of receiving recommended intensity. Among ASCVD patients, those with coronary artery disease were more likely to be on recommended intensity than cerebrovascular or peripheral vascular disease patients (OR 1.71, 95% CI 1.41–2.09), as were those seen by cardiologists (OR 1.43, 95% CI 1.12–1.83). Median LDL-C levels were highest among patients not on statins (124.0mg/dL), and slightly higher among those on lower-than-recommended intensity compared with recommended therapy recipients (88.0mg/dL and 84.0mg/dL, respectively, P ≤.0001). Conclusion In routine contemporary practice, one in four guideline-eligible patients were not on a statin; less than half were on the recommended statin intensity. Untreated and under-treated patients had significantly higher LDL-C levels than those receiving guideline-directed statin treatment.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.005
       
  • Contemporary Risk Model for In-hospital Major Bleeding for Patients with
           Acute Myocardial Infarction: The Acute Coronary Treatment and Intervention
           Outcomes Network (ACTION) Registry® -Get With the Guidelines (GWTG)®
    • Authors: Nihar R. Desai; Kevin F. Kennedy; David J. Cohen; Traci Connolly; Deborah B. Diercks; Mauro Moscucci; Stephen Ramee; John Spertus; Tracy Y. Wang; Robert L. McNamara
      Abstract: Publication date: Available online 12 August 2017
      Source:American Heart Journal
      Author(s): Nihar R. Desai, Kevin F. Kennedy, David J. Cohen, Traci Connolly, Deborah B. Diercks, Mauro Moscucci, Stephen Ramee, John Spertus, Tracy Y. Wang, Robert L. McNamara
      Background Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality. Objective To develop a contemporary model for in-hospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. Methods An in-hospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines (ACTION Registry - GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care. Results The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77–3.22]); presentation in cardiogenic shock (OR 2.22 [2.05–2.40]); STEMI (OR 1.72 [1.65–1.80]); presentation in heart failure (OR 1.55 [1.47–1.63]); baseline hemoglobin less than 12g/dL (1.55 [1.48–1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12–1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11–1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07–1.08]). The model discriminated well in the derivation (C-statistic=0.74) and validation (C-statistic=0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%). Conclusion The new ACTION Registry – GWTG in-hospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models.

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.004
       
  • Long-Term Outcomes of Bypass Grafting Versus Drug-Eluting Stenting for
           Left Main Coronary Artery Disease: Results from the IRIS-MAIN Registry
    • Authors: Pil Hyung Lee; Jong-Young Lee; Cheol Whan Lee; Seungbong Han; Jung-Min Ahn; Duk-Woo Park; Soo-Jin Kang; Seung-Whan Lee; Young-Hak Kim; Seong-Wook Park; Seung-Jung Park
      Abstract: Publication date: Available online 10 August 2017
      Source:American Heart Journal
      Author(s): Pil Hyung Lee, Jong-Young Lee, Cheol Whan Lee, Seungbong Han, Jung-Min Ahn, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Seong-Wook Park, Seung-Jung Park
      Background There are limited data on comparative outcomes and its determinants following coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for left main coronary artery disease (LMCAD) in a real-world setting. Methods A total of 3504 consecutive patients with LMCAD treated with CABG (n =1301) or PCI with DES (n =2203) from the IRIS-MAIN registry were analyzed. The relative treatment effect of one strategy over another was assessed by propensity-score matching method. The primary outcome was a composite of death, myocardial infarction, or stroke. Results Median follow-up duration was 4.7years. In the matched cohort, both groups demonstrated a similar risk for the primary outcome (adjusted hazard ratio [HR]: 0.94; 95% confidence interval [CI]: 0.77−1.15; P =.54). Compared with CABG, PCI exhibited higher risks of myocardial infarction (HR: 2.11; 95% CI: 1.16−3.83; P =.01) and repeated revascularization (HR: 5.95; 95% CI: 3.94−8.98; P <.001). In the overall population, age, presence of chronic kidney disease, and low ejection fraction (<40%) were key clinical predictors of primary outcome regardless of the treatment strategy. However, factors deemed to be associated with perioperative morbidity were determinants of primary outcome in the CABG group, whereas those generally associated with the severity of atherosclerotic coronary artery disease were strong predictors in the PCI group. Conclusions Among patients with significant LMCAD, the long-term risk of the composite outcome of death, myocardial infarction, or stroke was similar between CABG and PCI. Clinical variables that differentially predict adverse outcomes might be useful in triaging appropriate revascularization strategy

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.003
       
  • Biochemical Risk Markers and 10-Year Incidence of Atherosclerotic
           Cardiovascular Disease: Independent Predictors, Improvement in Pooled
           Cohort Equation, and Risk Reclassification
    • Authors: Emmanuel Akintoye; Alexandros Briasoulis; Luis Afonso
      Abstract: Publication date: Available online 10 August 2017
      Source:American Heart Journal
      Author(s): Emmanuel Akintoye, Alexandros Briasoulis, Luis Afonso
      Background The recommendation for statin in primary ASCVD prevention begins with risk estimation using the pooled cohort equation (PCE). However, treatment decision may still remain uncertain after PCE-based assessment. We therefore developed a simple biomarker score that could supplement decision-making. Methods Using the prospectively collected database of the Multi-ethnic Study of Atherosclerosis, we identified biochemical risk markers that independently predicted 10-year risk of ASCVD and developed an aggregate biomarker score based on them. Thereafter, we assessed for incremental benefit of these markers over the PCE using C-statistic, net reclassification index (NRI) and integrated discrimination index (IDI). Results 5303 adults free of ASCVD at baseline were included in this study. Five biochemical risk markers – hsCRP, homocysteine, albuminuria, NT-proBNP and troponin T– that predicted 10-year risk of ASCVD were combined into an aggregate biomarker score (CHAN2T3), which demonstrated a graded increase in the rate of incident ASCVD from 2.1% among participants with score of zero to 25% among participants with score of five. In addition, a biomarker score of ≥2 was associated with improvement in the C-statistic of the PCE (0.748 vs 0.734, P =.02), IDI (P <.001), category-free NRI of 45% (95% CI, 31–57%), and net categorical NRI of 5.4% in the full cohort. Lastly, a biomarker score of ≥4 resulted in 6% net reclassification across ASCVD risk cut-point of 7.5% among non-diabetics with LDL-C<190mg/dl. Conclusions A novel CHAN2T3 biomarker score could supplement risk-based discussion for ASCVD prevention, especially when treatment decision is uncertain. Further validation in other cohorts is however warranted

      PubDate: 2017-08-18T18:03:32Z
      DOI: 10.1016/j.ahj.2017.08.002
       
  • Temporal Trends and Hospital-Level Variation of In-Hospital Cardiac Arrest
           Incidence and Outcomes in the Veterans Health Administration
    • Authors: Steven M. Bradley; Peter Kaboli; Lee A. Kamphuis; Paul S. Chan; Anne E. Sales; Theodore J. Iwashyna; Brahmajee K. Nallamothu
      Abstract: Publication date: Available online 7 August 2017
      Source:American Heart Journal
      Author(s): Steven M. Bradley, Peter Kaboli, Lee A. Kamphuis, Paul S. Chan, Anne E. Sales, Theodore J. Iwashyna, Brahmajee K. Nallamothu
      Despite significant attention to resuscitation care by hospitals, national data on trends in the incidence and survival of patients with in-hospital cardiac arrest (IHCA) are limited. Objective To determine trends and hospital-level variation in the incidence and outcomes associated with IHCA. In exploratory analyses, we evaluated the relationship between hospital-level IHCA incidence and outcomes with general hospital-wide quality improvement activities. Design, Setting, and Participants Retrospective cohort study of 2,205,123 hospitalizations at 101 Veterans Health Administration (VHA) hospitals between 2008 and 2012. Main Outcomes Risk- and reliability-adjusted hospital-level IHCA incidence and survival to hospital discharge. Results A total of 8,821 (0.40%) IHCA occurred between 2008 and 2012, with no significant change in risk-adjusted incidence over this time (p=0.77). Hospital-level IHCA incidence varied substantially across facilities, with a median hospital incidence of 4.0 per 1000 hospitalizations and a range from 1.4 to 11.8 per 1000 hospitalizations. Overall, survival to discharge after IHCA was 31.2%. Risk-adjusted odds of survival increased over the study period (2012 vs 2008, OR: 1.49, 95% CI: 1.27, 1.75) but survival varied substantially across facilities from 20.3% to 45.4%. General hospital quality improvement activities were inconsistently associated with IHCA incidence and survival. Conclusions Within the VHA, the incidence and outcomes of IHCA showed important trends over time but varied substantially across hospitals with no consistent link to general hospital quality improvement activities. Identification of specific resuscitation practices at hospitals with low incidence and high survival of IHCA may guide further improvements for in-hospital resuscitation.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.05.018
       
  • Association Between Hospital Rates of Early Do-Not-Resuscitate Orders and
           Favorable Neurological Survival Among Survivors of In-Hospital Cardiac
           Arrest
    • Authors: Timothy J. Fendler; John A. Spertus; Kevin F. Kennedy; Paul S. Chan
      Abstract: Publication date: Available online 7 August 2017
      Source:American Heart Journal
      Author(s): Timothy J. Fendler, John A. Spertus, Kevin F. Kennedy, Paul S. Chan
      Background Current guidelines recommend deferring prognostication for 48–72hours after resuscitation from in-hospital cardiac arrest. It is unknown whether hospitals vary in making patients who survive an arrest Do-Not-Resuscitate (DNR) early after resuscitation and whether a hospital's rate of early DNR is associated with its rate of favorable neurological survival. Methods Within Get With the Guidelines-Resuscitation, we identified 24,899 patients from 236 hospitals who achieved return of spontaneous circulation (ROSC) after in-hospital cardiac arrest between 2006 and 2012. Hierarchical models were constructed to derive risk-adjusted hospital rates of DNR status adoption ≤12hours after ROSC and risk-standardized rates of favorable neurological survival (without severe disability; Cerebral Performance Category ≤2). The association between hospitals' rates of early DNR and favorable neurological survival was evaluated using correlation statistics. Results Of 236 hospitals, 61.7% were academic, 83% had ≥200 beds, and 94% were urban. Overall, 5577 (22.4%) patients were made DNR ≤12hours after ROSC. Risk-adjusted hospital rates of early DNR varied widely (7.1%–40.5%, median: 22.7% [IQR: 19.3%–26.1%]; median OR of 1.48). Significant hospital variation existed in risk-standardized rates of favorable neurological survival (3.5%–44.8%, median: 25.3% [IQR: 20.2%–29.4%]; median OR 1.72). Hospitals' risk-adjusted rates of early DNR were inversely correlated with their risk-standardized rates of favorable neurological survival (r=−0.179, P =.006). Conclusions Despite current guideline recommendations, many patients with in-hospital cardiac arrest are made DNR within 12hours after ROSC, and hospitals vary widely in rates of early DNR. Higher hospital rates of early DNR were associated with worse meaningful survival outcomes

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.05.017
       
  • In-Hospital Cardiac Arrest: Complex Clinical Challenges in Need of Unique
           Solutions
    • Authors: Angela Lowenstern; Anant Mandawat; L. Kristin Newby
      Abstract: Publication date: Available online 5 August 2017
      Source:American Heart Journal
      Author(s): Angela Lowenstern, Anant Mandawat, L. Kristin Newby


      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.021
       
  • Rationale of a Novel Study Design for the BIOFLOW V Study, a Prospective,
           Randomized Multicenter Study to Assess the Safety and Efficacy of the
           Orsiro Sirolimus-Eluting Coronary Stent System Utilizing a Bayesian
           Approach
    • Authors: Gheorghe Doros; Joseph M. Massaro; David E. Kandzari; Ron Waksman; Jacques J. Koolen; Donald E. Cutlip; Laura Mauri
      Abstract: Publication date: Available online 5 August 2017
      Source:American Heart Journal
      Author(s): Gheorghe Doros, Joseph M. Massaro, David E. Kandzari, Ron Waksman, Jacques J. Koolen, Donald E. Cutlip, Laura Mauri
      Background Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design employing the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that utilize durable polymers for drug-elution. Study Design and Objectives This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES vs. the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from two similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW-II, N=452, and BIOFLOW IV N=579) by employing a Bayesian approach. The primary endpoint is target lesion failure (TLF) at 12 months post-index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES vs. DP EES on the primary endpoint according to a non-inferiority delta of 3.85%. Secondary endpoints include stent thrombosis, and the individual components of TLF. Subjects will be followed for 5 years after randomization. Conclusions The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients with two smaller contributing randomized trials to augment the efficiency of the comparison.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.08.001
       
  • Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the
           Assessment of Non-Culprit Lesions during the Index Procedure in Patients
           with ST-Segment Elevation Myocardial Infarction: The WAVE study
    • Authors: Carmine Musto; Francesco De Felice; Stefano Rigattieri; Diana Chin; Andrea Marra; Marco Stefano Nazzaro; Alberta Cifarelli; Roberto Violini
      Abstract: Publication date: Available online 3 August 2017
      Source:American Heart Journal
      Author(s): Carmine Musto, Francesco De Felice, Stefano Rigattieri, Diana Chin, Andrea Marra, Marco Stefano Nazzaro, Alberta Cifarelli, Roberto Violini
      Background Functional assessment of non-infarct-related artery (nIRA) lesions during primary percutaneous coronary intervention (PCI) might be useful in order to avoid revascularization of non-significant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared to fractional flow reserve (FFR) in this setting. Methods In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5–8days after). Results Paired iFR and FFR measurements were available for 66 non-IRA lesions in 50 patients. The iFR and FFR values of non-IRA lesions did not change significantly between the index and staged procedure. Bland–Altman analysis did not show systematic bias for either iFR or FFR repeated measures. ROC curve analysis showed high accuracy of iFR to identify a positive (≤ 0.80) FFR measurements in the index procedure with an area under curve of 0.95. A cut-off of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with a positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r=0.71, r2 =0.51; P <.0001). Conclusions The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non-IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine-free.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.017
       
  • Regional variation in quality of life in patients with a Fontan
           circulation - A multinational perspective
    • Authors: Nicholas D. Fogleman; Silke Apers; Philip Moons; Stacey Morrison; Samuel G. Wittekind; Martha Tomlin; Kathy Gosney; Maayke A. Sluman; Bengt Johansson; Junko Enomoto; Mikael Dellborg; Chun-Wei Lu; Raghavan Subramanyan; Koen Luyckx; Werner Budts; Jamie Jackson; Adrienne Kovacs; Alexandra Soufi; Katrine Eriksen; Corina Thomet; Malin Berghammer; Edward Callus; Susan M. Fernandes; Maryanne Caruana; Stephen C. Cook; Andrew S. Mackie; Kamila S. White; Paul Khairy; Shelby Kutty; Gruschen Veldtman
      Abstract: Publication date: Available online 2 August 2017
      Source:American Heart Journal
      Author(s): Nicholas D. Fogleman, Silke Apers, Philip Moons, Stacey Morrison, Samuel G. Wittekind, Martha Tomlin, Kathy Gosney, Maayke A. Sluman, Bengt Johansson, Junko Enomoto, Mikael Dellborg, Chun-Wei Lu, Raghavan Subramanyan, Koen Luyckx, Werner Budts, Jamie Jackson, Adrienne Kovacs, Alexandra Soufi, Katrine Eriksen, Corina Thomet, Malin Berghammer, Edward Callus, Susan M. Fernandes, Maryanne Caruana, Stephen C. Cook, Andrew S. Mackie, Kamila S. White, Paul Khairy, Shelby Kutty, Gruschen Veldtman
      Background Impaired quality of life (QOL) is associated with congenital heart disease (CHD) and country of residence; however, few studies have compared QOL in patients with differing complexities of CHD across regional populations. The current study examined regional variation in QOL outcomes in a large multinational sample of patients with a Fontan relative to patients with atrial septal defects (ASD) and ventricular septal defects (VSD). Methods From the Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study (APPROACH-IS) study, 405 patients (163 Fontan and 242 ASD/VSD) across Asia, Europe and North America provided consent for access to their medical records and completed a survey evaluating QOL (0 to 100 Linear Analog Scale). Primary CHD diagnosis, disease complexity, surgical history, and documented history of mood and anxiety disorders were recorded. Differences in QOL, medical complications, and mood and anxiety disorders between Fontan and ASD/VSD patients, and across geographic regions, were examined using ANCOVA. Hierarchical regression analyses were conducted to identify variables associated with the QOL ratings. Results Patients with a Fontan reported significantly lower QOL, and greater medical complications and mood and anxiety disorders relative to patients with ASD/VSD. Inpatient cardiac admissions, mood disorders and anxiety disorders were associated with lower QOL among patients with a Fontan and mood disorders were associated with lower QOL among patients with ASD/VSD. Regional differences for QOL were not observed in patients with a Fontan; however, significant differences were identified in patients with ASD/VSD. Conclusion Regional variation of QOL is commonplace in adults with CHD; however, it appears affected by greater disease burden. Among patients with a Fontan, regional variation of QOL is lost. Specific attempts to screen for QOL and mood and anxiety disorders among CHD patients may improve the care of patients with the greatest disease burden. Translational Perspective Fontan patients have among the highest degree of disease complexity in individuals affected with congenital heart disease. During late follow-up, they have some of the highest rates of cardiac and extra-cardiac medical complications necessitating inpatient admission. This high disease burden very significantly affects QOL. Although this is a cross-sectional study examining QOL in a large multinational cohort of adult with congenital heart disease, concerted efforts should be made to screen for QOL and mood and anxiety disorders in those with greatest disease burden and proactively addressed.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.019
       
  • Association between Influenza Vaccination and Reduced Risks of Major
           Adverse Cardiovascular Events in Elderly Patients
    • Authors: Ming-Hsien Chiang; Hau-Hsin Wu; Chia-Jen Shih; Yung-Tai Chen; Shu-Chen Kuo; Te-Li Chen
      Abstract: Publication date: Available online 2 August 2017
      Source:American Heart Journal
      Author(s): Ming-Hsien Chiang, Hau-Hsin Wu, Chia-Jen Shih, Yung-Tai Chen, Shu-Chen Kuo, Te-Li Chen
      Background This study was conducted to determine the protective effect of influenza vaccine against primary major adverse cardiovascular events (MACEs) in elderly patients, especially those with influenza-like illness (ILI). Methods This retrospective, population-based case–control study of an elderly population (age≥65years) was conducted using Taiwan's National Health Insurance Research Database (2000–2013). One control was selected for each MACE case (n =80,363 each), matched according to age, year of study entry, and predisposing factors for MACEs. ILI and MACEs (myocardial infarction [MI] and ischemic stroke) were defined according to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Odds ratios (ORs) were calculated for the association between MACEs and vaccination. Results Influenza vaccination received in the previous year was associated with reduced risks of primary MACEs overall (adjusted OR [aOR] 0.80, 95% confidence interval [CI] 0.78–0.82, P <.001), MI (aOR 0.80, 95% CI 0.76–0.84, P <.001), and ischemic stroke (aOR 0.80, 95% CI 0.77–0.82, P <.001). ILI diagnosed in the previous year was associated with increased risks of MACEs (aOR 1.24, 95% CI 1.18–1.29, P <.001), MI (aOR 1.46, 95% CI 1.34–1.59, P <.001), and ischemic stroke (aOR 1.16, 95% CI 1.10–1.22, P <.001). Vaccination attenuated the heightened risks associated with ILI (MACEs: aOR 0.99, 95% CI 0.92–1.07, P =.834; MI: aOR 1.05, 95% CI 0.92–1.21, P =.440; ischemic stroke: aOR 0.96, 95% CI 0.89–1.05, P =.398). Conclusions Results of this study suggest that influenza vaccination is associated with reduced primary MACE risks in the elderly population, including those with ILI.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.020
       
  • Does renal function affect the efficacy or safety of a pharmacoinvasive
           strategy in patients with ST-elevation myocardial infarction' A
           meta-analysis
    • Authors: Juan J Russo; Shaun G Goodman; Warren J Cantor; Dennis T Ko; Akshay Bagai; Mary K Tan; Carlo Di Mario; Sigrun Halvorsen; Michel Le May; Francisco Fernandez-Avilés; Bruno Scheller; Paul W Armstrong; Francesco Borgia; Federico Piscione; Pedro L Sanchez; Andrew T Yan
      Abstract: Publication date: Available online 2 August 2017
      Source:American Heart Journal
      Author(s): Juan J Russo, Shaun G Goodman, Warren J Cantor, Dennis T Ko, Akshay Bagai, Mary K Tan, Carlo Di Mario, Sigrun Halvorsen, Michel Le May, Francisco Fernandez-Avilés, Bruno Scheller, Paul W Armstrong, Francesco Borgia, Federico Piscione, Pedro L Sanchez, Andrew T Yan
      Background The efficacy and safety of pharmacoinvasive strategy following fibrinolysis for ST-elevation myocardial infarction (STEMI) in relation to renal function have not been established. Methods Using patient-level data from four randomized controlled trials, we examined the efficacy and safety of pharmacoinvasive versus standard treatment after fibrinolysis for STEMI. Patients were stratified based on the estimated glomerular filtration rate (eGFR) on presentation (<60ml/min/1.73m2 versus ≥60ml/min/1.73m2). The primary outcome was the composite of death or re-infarction at 30days. Results Of 2029 patients, 457 (23%) had an eGFR<60ml/min/1.73m2. Patients with eGFR<60ml/min/1.73m2 were older and had higher TIMI risk scores. Compared to patients with eGFR≥60ml/min/1.73m2, patients with renal dysfunction had higher rates of the primary outcome (5.3% versus 11.8%, respectively; P <.001). There was no significant heterogeneity in the treatment effect of pharmacoinvasive strategy on the primary outcome (p-heterogeneity=0.73) or the rate of death or re-infarction at one year (p-heterogeneity=0.64) in relation to eGFR. Patients with renal dysfunction had higher rates of in-hospital major bleeding compared to patients with eGFR ≥60ml/min/1.73m2 (7.7% versus 4.3%, respectively; P =.004); however, there was no difference in bleeding events between treatment arms in the overall cohort or in relation to eGFR (p-heterogeneity=0.67). Conclusion Renal impairment is associated with increased rates of adverse events in STEMI patients treated with fibrinolysis. However, the safety and efficacy of pharmacoinvasive strategy are preserved in patients with renal impairment on presentation.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.015
       
  • Temporal Changes in Infective Endocarditis Guidelines during the last 12
           years: High-level Evidence Needed
    • Authors: Lauge Østergaard; Nana Valeur; Henning Bundgaard; Jawad H. Butt; Nikolaj Ihlemann; Lars Køber; Emil L. Fosbøl
      Abstract: Publication date: Available online 2 August 2017
      Source:American Heart Journal
      Author(s): Lauge Østergaard, Nana Valeur, Henning Bundgaard, Jawad H. Butt, Nikolaj Ihlemann, Lars Køber, Emil L. Fosbøl
      Aims Infective endocarditis (IE) is a complex disease necessitating extensive clinical guidelines. The guidelines from the American Heart Association (AHA) and the European Society of Cardiology (ESC) have been markedly extended during the last 12 years. We examined the evidence base for these changes. Methods and results IE guidelines published by AHA and ESC were reviewed. We categorized and combined guidelines in three time periods: 1) 2004 (AHA) and 2005 (ESC), 2) 2007 (AHA) and 2009 (ESC), 3) 2015 (AHA) and 2015 (ESC). Number of recommendations, classes of recommendations (I, II, or III), and levels of evidence (LOE) (A, B, or C) were assessed and the changes over time. From period 1 to period 3 we found a statistical significant increase in total number of IE recommendations from 37 to 253 (p<0.01), a 6.8 fold increase. There was a significant decrease in LOE A (from 7 [20.0%] in period 1 to 4 [1.6%] in period 3, p<0.0001, a 57% decrease); a nonsignificant decrease in LOE B recommendations (from 17 [48.6%] in period 1 to 115 [45.9%] in period 3, p=0.29, a 6.8 fold increase), and a significant increase in LOE C recommendations (from 11 [31.4%] in period 1 to 134 [53.0%] in period 3, p=0.02, a 12.2 fold increase). Conclusions The number of IE guideline recommendations has increased 6-7 fold during the last decade without a corresponding increase in evidence. These results highlight the strong need for more clinical studies to improve the level of evidence in IE guidelines.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.018
       
  • Comparison of Prevalence and Management of Left-Atrial Appendage Thrombi
           under Old and New Anticoagulants Prior to Left-Atrial Catheter Ablation
    • Authors: Antoine Da Costa; Clarisse Delolme; Jean Baptiste Guichard; Antoine Gerbay; Romain Pierrard; Cécile Romeyer-Bouchard; Karl Isaaz
      Abstract: Publication date: Available online 2 August 2017
      Source:American Heart Journal
      Author(s): Antoine Da Costa, Clarisse Delolme, Jean Baptiste Guichard, Antoine Gerbay, Romain Pierrard, Cécile Romeyer-Bouchard, Karl Isaaz
      Background The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants (NOACs) remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to: compare the prevalence of LAA thrombi and/or severe LAA contrast under VKA agents and NOACs; evaluate the rate of LAA thrombus resolution after anticoagulation modification; determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation. Methods and results Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included and the prevalence of TEE-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%). Thrombus resolution was obtained in 50% of cases, following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P <.001), LAA hypocontractility (P <.001), and left ventricular ejection fraction (LVEF) (P =.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P <.001) and age (P <.001). Conclusions The prevalence of TEE-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3–4 international normalized ratio (INR), 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and LVEF.

      PubDate: 2017-08-07T17:39:32Z
      DOI: 10.1016/j.ahj.2017.07.016
       
  • Information for Readers
    • Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190


      PubDate: 2017-07-30T17:25:43Z
       
  • Regional Differences in Presentation and Antithrombotic Treatment of
           Patients with Atrial Fibrillation: Baseline Characteristics from a
           Clustered Randomized Trial to IMProve treatment with AntiCoagulanTs in
           patients with Atrial Fibrillation (IMPACT-AF)
    • Authors: Dragos Vinereanu; Hussein R. Al-Khalidi; Meena P. Rao; Wensheng He; Renato D. Lopes; Cecilia M. Bahit; Andrea O. Ciobanu; Kathleen A. Fox; Sean D. Pokorney; Ying Xian; Jie Jiang; Deepak Y. Kamath; Otavio Berwanger; Carlos Tajer; Yong Huo; Denis Xavier; Christopher B. Granger
      Abstract: Publication date: Available online 14 July 2017
      Source:American Heart Journal
      Author(s): Dragos Vinereanu, Hussein R. Al-Khalidi, Meena P. Rao, Wensheng He, Renato D. Lopes, Cecilia M. Bahit, Andrea O. Ciobanu, Kathleen A. Fox, Sean D. Pokorney, Ying Xian, Jie Jiang, Deepak Y. Kamath, Otavio Berwanger, Carlos Tajer, Yong Huo, Denis Xavier, Christopher B. Granger
      Background Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there are few contemporary comparative data on AF from middle-income countries. Methods Baseline characteristics of the IMPACT-AF trial were analyzed to assess regional differences in presentation and antithrombotic treatment of AF from 5 middle-income countries (Argentina, Brazil, China, India, and Romania), and factors associated with antithrombotic treatment prescription. Results IMPACT-AF enrolled 2281 patients (69±11 years, 47% women) at 48 sites. Overall, 66% of patients were on anticoagulation at baseline, ranging from 38% in China to 91% in Brazil. The top 3 reasons for not prescribing an anticoagulant were patient preference/refusal (26%), concomitant antiplatelet therapy (15%), and risks outweighing the benefits, as assessed by the physician (13%). In a multivariable model, the most significant factors associated with prescription of oral anticoagulants were no prior major bleeding (OR=4.34; 95% CI=2.22–8.33), no alcohol abuse (OR=2.27; 95% CI=1.12–4.55), and history of rheumatic valvular heart disease (OR=2.10; 95% CI=1.36–3.26), with a strong predictive accuracy (c-statistic=0.85), whereas the most significant factors associated with prescription of a combination of oral anticoagulants and antiplatelet drugs were prior coronary revascularization (OR=5.10; 95% CI=2.88–9.05), prior myocardial infarction (OR=2.24; 95% CI=1.38–3.63), and no alcohol abuse (OR=2.22; 95% CI=1.11–4.55), with a good predictive accuracy (c-statistic=0.76). Conclusion IMPACT-AF provides contemporary data from 5 middle-income countries regarding antithrombotic treatment of AF. Lack of prior major bleeding and coronary revascularization were the most important factors associated with prescription of oral anticoagulants and their combination with antiplatelet drugs, respectively. Trial registration ClinicalTrials.gov number, NCT02082548.

      PubDate: 2017-07-23T17:04:04Z
      DOI: 10.1016/j.ahj.2017.07.004
       
  • Galectin-3 and Incidence of Atrial Fibrillation: the Atherosclerosis Risk
           in Communities (ARIC) Study
    • Authors: Oluwaseun E. Fashanu; Faye L. Norby; David Aguilar; Christie M. Ballantyne; Ron C. Hoogeveen; Lin Y. Chen; Elsayed Z. Soliman; Alvaro Alonso; Aaron R. Folsom
      Abstract: Publication date: Available online 8 July 2017
      Source:American Heart Journal
      Author(s): Oluwaseun E. Fashanu, Faye L. Norby, David Aguilar, Christie M. Ballantyne, Ron C. Hoogeveen, Lin Y. Chen, Elsayed Z. Soliman, Alvaro Alonso, Aaron R. Folsom
      Background Galectin-3, a beta-galactoside binding lectin involved in important regulatory roles in adhesion, inflammation, immunity, and fibrosis, may be relevant to atrial fibrillation (AF) etiology. Methods We included 8436 participants free of AF at baseline (1996–98) and with measures of plasma galectin-3 from the Atherosclerosis Risk in Communities (ARIC) study. We ascertained incident AF through 2013 from study visit ECGs, hospitalizations and death certificates. Multivariable Cox proportional hazards models, adjusted for AF risk factors plus incident HF and CHD, were used to estimate hazard ratios for the association between galectin-3 and incident AF. Results The mean age (SD) of participants was 62.6 (5.6) years and was comprised of 58.7% women and 21.2% blacks. During a median follow-up of 15.7years, 1185 incident cases of AF were observed. After adjusting for AF risk factors, participants with galectin-3 levels ≥90th percentile (19.5ng/mL) had a significantly higher risk of incident AF when compared to the lowest quartile (4.4–11.9ng/mL), with hazard ratios (95% confidence interval) of 1.40 (1.04–1.89) for the 90th – <95th percentile and 1.51 (1.11–2.06) for the 95th – 100th percentile. This association was attenuated and no longer statistically significant after accounting for incident CHD and HF as time dependent variables. Conclusions Elevated plasma galectin-3 is associated with increased risk of incident AF. Galectin-3 may increase AF risk via pathways involving CHD and HF.

      PubDate: 2017-07-12T16:44:13Z
      DOI: 10.1016/j.ahj.2017.07.001
       
  • New York Heart Association Class and the Survival Benefit from Primary
           Prevention Implantable Cardioverter Defibrillators: A Pooled Analysis of 4
           Randomized Controlled Trials
    • Authors: Daniel J. Friedman; Sana M. Al-Khatib; Emily P. Zeitler; JooYoon Han; Gust H. Bardy; Jeanne E. Poole; J. Thomas Bigger; Alfred E. Buxton; Arthur J. Moss; Kerry L. Lee; Richard Steinman; Paul Dorian; Riccardo Cappato; Alan H. Kadish; Peter J. Kudenchuk; Daniel B. Mark; Lurdes Y.T. Inoue; Gillian D. Sanders
      Abstract: Publication date: Available online 9 June 2017
      Source:American Heart Journal
      Author(s): Daniel J. Friedman, Sana M. Al-Khatib, Emily P. Zeitler, JooYoon Han, Gust H. Bardy, Jeanne E. Poole, J. Thomas Bigger, Alfred E. Buxton, Arthur J. Moss, Kerry L. Lee, Richard Steinman, Paul Dorian, Riccardo Cappato, Alan H. Kadish, Peter J. Kudenchuk, Daniel B. Mark, Lurdes Y.T. Inoue, Gillian D. Sanders
      Background Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure (HF) derive ICD benefit owing to the competing risk of non-sudden death. Methods We performed a patient level meta-analysis of New York Heart Association class (NYHA) class II/III HF patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian–Weibull survival regression models were employed to assess the impact of NYHA class on the relationship between ICD use and mortality. Results Of the 2763 patients who met study criteria, 68% (n=1867) were NYHA II and 52% (n=1435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality [HR 0.65, 95% posterior credibility interval (PCI) 0.40–0.99]. The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=0.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35–0.85) and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48–1.24) although this was not statistically significant. Conclusions Primary prevention ICDs reduce mortality in NYHA class II patients and trend towards reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.

      PubDate: 2017-06-13T16:47:53Z
      DOI: 10.1016/j.ahj.2017.06.002
       
  • Growth-Differentiation Factor 15 and Risk of Major Bleeding in Atrial
           Fibrillation: Insights from the RE-LY Trial
    • Authors: Ziad Hijazi; Jonas Oldgren; Ulrika Andersson; Stuart J. Connolly; John W. Eikelboom; Michael D. Ezekowitz; Paul A. Reilly; Salim Yusuf; Agneta Siegbahn; Lars Wallentin
      Abstract: Publication date: Available online 6 June 2017
      Source:American Heart Journal
      Author(s): Ziad Hijazi, Jonas Oldgren, Ulrika Andersson, Stuart J. Connolly, John W. Eikelboom, Michael D. Ezekowitz, Paul A. Reilly, Salim Yusuf, Agneta Siegbahn, Lars Wallentin
      Objective To evaluate and validate the prognostic value of Growth-Differentiation Factor-15 (GDF-15) beyond clinical characteristics and other biomarkers concerning bleeding and stroke outcomes in patients with AF in the RE-LY trial. Methods GDF-15 was measured in samples collected at randomization in 8474 patients with a median follow-up time of 1.9 years. Patients were stratified based on pre-defined GDF-15 cut-offs: group 1:<1200 ng/L (the 90th percentile in healthy individuals), group 2:1200–1800, and group 3:>1800 ng/L (high-risk individuals). Efficacy and safety outcomes were compared across groups of GDF-15 in Cox models adjusted for baseline characteristics, cardiac (NT-proBNP, hs-troponin T), inflammatory (IL-6, CRP) and coagulation (D-dimer) biomarkers, and randomized treatment. Results GDF-15 concentrations were below 1200 ng/L in 2,647 (31.2%), between 1200 and 1800 ng/L in 2,704 (31.9%), and above 1800 ng/L in 3,123 (36.9%) participants, respectively. Annual rates of stroke, major bleeding, and mortality increased with higher GDF-15 levels. The prognostic value of GDF-15 was independent of clinical characteristics for these outcomes. In models also adjusted for biomarkers, GDF-15 remained significantly associated with major bleeding (HR (95% CI) group 3 vs. group 1 1.76 (1.28–2.42, p<0.0005) and all-cause mortality (HR 1.72 (1.30–2.29, p<0.0005). GDF-15 improved the C-index of both the HAS-BLED (0.62 to 0.69) and ORBIT (0.68 to 0.71) bleeding risk scores. Conclusions In patients with AF, GDF-15 is an independent risk indicator for major bleeding and all-cause mortality, but not for stroke. Therefore, GDF-15 seems useful as a specific marker of bleeding in patients with AF on oral anticoagulant treatment.

      PubDate: 2017-06-09T10:31:17Z
      DOI: 10.1016/j.ahj.2017.06.001
       
  • Time in therapeutic range and major adverse outcomes in atrial
           fibrillation patients undergoing percutaneous coronary intervention: the
           AFCAS Registry
    • Authors: Marco Proietti; K.E. Juhani Airaksinen; Andrea Rubboli; Axel Schlitt; Tuomas Kiviniemi; Pasi P. Karjalainen; Gregory YH Lip
      Abstract: Publication date: Available online 3 June 2017
      Source:American Heart Journal
      Author(s): Marco Proietti, K.E. Juhani Airaksinen, Andrea Rubboli, Axel Schlitt, Tuomas Kiviniemi, Pasi P. Karjalainen, Gregory YH Lip
      Background Combination of oral anticoagulation (OAC) and antiplatelets is used in atrial fibrillation (AF) patients undergoing percutaneous coronary intervention and stent (PCI-S) procedure, but is associated with increased bleeding when triple antithrombotic therapy (TAT) is used. Our aim was to analyse the impact of time in therapeutic range (TTR) on outcomes, in patients prescribed with TAT. Methods Ancillary analysis from the AFCAS registry in patients assigned to TAT. TTR was calculated with Rosendaal method. Outcomes were analysed according to TTR tertiles (T1[≤56.8%]vs.T2[56.9–93.8%]vs.T3[≥93.9%]). Major bleeding was the primary outcome. Results Of 963 patients enrolled, 470(48.8%) were prescribed with TAT at discharge and qualified for this analysis. Median [IQR] TTR was 80.0%[45.3–100%]. After 359[341–370] days, major bleeding rates were progressively lower with increasing TTR tertiles (T1vs.T2vs.T3:10.3%vs.4.7%vs.2.3%,P =.006). Kaplan–Meier analysis demonstrated a progressively lower risk for major bleeding across tertiles (P =.006). Patients in the highest TTR tertile had a non-significant lower risk for major adverse coronary and cerebrovascular events (MACCE)(Log-Rank: 4.905, P =.086). Cox regression analysis showed that T2 and T3 were inversely associated with major bleeding (hazard ratio[HR]:0.39,P =.050 and HR:0.21,P =.005). Continuous TTR was inversely associated with major bleeding (HR:0.98,P <.001). For MACCE, adjusted Cox analysis found a non-significant lower risk for T3 (HR:0.64,P =.128). Conclusions In AF patients undergoing PCI-S prescribed TAT, good quality anticoagulation control (as reflected by TTR) was closely related to bleeding outcomes during follow-up. Despite some suggestive trends for an inverse relationship between TTR and MACCE, no definitive conclusions can be drawn, and further large studies are needed.

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.016
       
  • A randomised trial of a 1-hour troponin T protocol in suspected acute
           coronary syndromes: Design of the Rapid Assessment of Possible ACS In the
           emergency Department with high sensitivity Troponin T (RAPID-TnT) Study
    • Authors: Cynthia Papendick; Andrew Blyth; Anil Seshadri; Michael JR Edmonds; Tom Briffa; Louise Cullen; Stephen Quinn; Jon Karnon; Anthony Chuang; Adam J Nelson; Matthew Horsfall; Erin Morton; Derek P Chew
      Abstract: Publication date: Available online 18 May 2017
      Source:American Heart Journal
      Author(s): Cynthia Papendick, Andrew Blyth, Anil Seshadri, Michael JR Edmonds, Tom Briffa, Louise Cullen, Stephen Quinn, Jon Karnon, Anthony Chuang, Adam J Nelson, Matthew Horsfall, Erin Morton, Derek P Chew
      Background Protocols incorporating high sensitivity troponin to guide decision making in the disposition of suspected ACS patients in the emergency department (ED) have received a lot of attention. Traditionally, chest pain patients have required long periods of observation in ED before being deemed safe for discharge. In an era of limited health service resources, a protocol that could discharge patients safely within an hour of presentation is extremely attactive. Unfortunately, despite incorporation into some guidelines, these protocols have not been subjected to randomized comparisons evaluating safety, effectiveness and cost-effectiveness. Objective This study is designed to provide the evidence required to allow key decision makers to implement these protocols. Specifically, to provide evidence that a decision-rule based on 0 and 1hour high-sensitivity troponin T (hs-TnT) is safe, provides non-inferior outcomes in all suspected ACS patients, and that implementation of a rapid troponin protocol leads to efficient care. Design This prospective pragmatic trial (n=5400, 5 hospitals) randomly allocates suspected ACS patients to either a 0/1-hour hs-TnT protocol as advocated in clinical guidelines, versus usual care of standard troponin reporting evaluated at 3 and 6hours. The primary effectiveness composite endpoint of this study is all-cause death, new/recurrent ACS within 30days. To evaluate cost-effectiveness, follow-up will determine clinical events, quality of life and resource utilizationwithin 12-months.

      PubDate: 2017-05-19T14:29:24Z
      DOI: 10.1016/j.ahj.2017.05.004
       
  • Probing oral anticoagulation in patients with atrial high rate episodes.
           Rationale and design of the Non vitamin K antagonist Oral anticoagulants
           in patients with Atrial High rate episodes (NOAH – AFNET 6) trial
    • Authors: Paulus Kirchhof; Benjamin F Blank; Melanie Calvert; A John Camm; Gregory Chlouverakis; Hans-Christoph Diener; Andreas Goette; Andrea Huening; Gregory Y.H. Lip; Emmanuel Simantirakis; Panos Vardas
      Abstract: Publication date: Available online 3 May 2017
      Source:American Heart Journal
      Author(s): Paulus Kirchhof, Benjamin F Blank, Melanie Calvert, A John Camm, Gregory Chlouverakis, Hans-Christoph Diener, Andreas Goette, Andrea Huening, Gregory Y.H. Lip, Emmanuel Simantirakis, Panos Vardas
      Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation. Early detection of atrial fibrillation and subsequent initiation of oral anticoagulation help to prevent strokes in atrial fibrillation patients. Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes (AHRE), but the best antithrombotic therapy in patients with AHRE is not known. Rationale Stroke risk is higher in pacemaker patients with AHRE than in those without, but the available data also show that stroke risk in patients with AHRE is lower than in patients with atrial fibrillation. Furthermore, only a minority of patients with AHRE will develop AF, many strokes occur without a temporal relation to AHRE, and AHRE can reflect other arrhythmias than AF or artefacts. An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed. Design The NOAH – AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared to aspirin or no antithrombotic therapy based on evidence-based indications. The primary safety outcome will be major bleeding. NOAH – AFNET 6 will randomise 3400 patients with AHRE, but without documented AF, aged 65 or older with at least one other stroke risk factor, to oral anticoagulation therapy (edoxaban) or no anticoagulation. All patients will be followed until the end of this investigator-driven, prospective, parallel-group, randomised, event-driven, double-blind, multi-centre phase IIIb trial. Patients will be censored when they develop atrial fibrillation and offered open label anticoagulation. The sponsor is the Atrial Fibrillation NETwork (AFNET). The trial is supported by the DZHK (German Centre for Cardiovascular Research), by the BMBF (German Ministry of Education and Research) and by Daiichi Sankyo Europe. Conclusion NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices.
      Graphical abstract image

      PubDate: 2017-05-04T12:08:37Z
      DOI: 10.1016/j.ahj.2017.04.015
       
 
 
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