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Publisher: Elsevier   (Total: 3184 journals)

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Showing 1 - 200 of 3184 Journals sorted alphabetically
Academic Pediatrics     Hybrid Journal   (Followers: 37, SJR: 1.655, CiteScore: 2)
Academic Radiology     Hybrid Journal   (Followers: 26, SJR: 1.015, CiteScore: 2)
Accident Analysis & Prevention     Partially Free   (Followers: 100, SJR: 1.462, CiteScore: 3)
Accounting Forum     Hybrid Journal   (Followers: 28, SJR: 0.932, CiteScore: 2)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 40, SJR: 1.771, CiteScore: 3)
Achievements in the Life Sciences     Open Access   (Followers: 6)
Acta Anaesthesiologica Taiwanica     Open Access   (Followers: 7)
Acta Astronautica     Hybrid Journal   (Followers: 435, SJR: 0.758, CiteScore: 2)
Acta Automatica Sinica     Full-text available via subscription   (Followers: 2)
Acta Biomaterialia     Hybrid Journal   (Followers: 28, SJR: 1.967, CiteScore: 7)
Acta Colombiana de Cuidado Intensivo     Full-text available via subscription   (Followers: 3)
Acta de Investigación Psicológica     Open Access   (Followers: 3)
Acta Ecologica Sinica     Open Access   (Followers: 11, SJR: 0.18, CiteScore: 1)
Acta Histochemica     Hybrid Journal   (Followers: 3, SJR: 0.661, CiteScore: 2)
Acta Materialia     Hybrid Journal   (Followers: 309, SJR: 3.263, CiteScore: 6)
Acta Mathematica Scientia     Full-text available via subscription   (Followers: 5, SJR: 0.504, CiteScore: 1)
Acta Mechanica Solida Sinica     Full-text available via subscription   (Followers: 9, SJR: 0.542, CiteScore: 1)
Acta Oecologica     Hybrid Journal   (Followers: 12, SJR: 0.834, CiteScore: 2)
Acta Otorrinolaringologica (English Edition)     Full-text available via subscription  
Acta Otorrinolaringológica Española     Full-text available via subscription   (Followers: 2, SJR: 0.307, CiteScore: 0)
Acta Pharmaceutica Sinica B     Open Access   (Followers: 1, SJR: 1.793, CiteScore: 6)
Acta Poética     Open Access   (Followers: 4, SJR: 0.101, CiteScore: 0)
Acta Psychologica     Hybrid Journal   (Followers: 25, SJR: 1.331, CiteScore: 2)
Acta Sociológica     Open Access   (Followers: 1)
Acta Tropica     Hybrid Journal   (Followers: 6, SJR: 1.052, CiteScore: 2)
Acta Urológica Portuguesa     Open Access  
Actas Dermo-Sifiliograficas     Full-text available via subscription   (Followers: 3, SJR: 0.374, CiteScore: 1)
Actas Dermo-Sifiliográficas (English Edition)     Full-text available via subscription   (Followers: 2)
Actas Urológicas Españolas     Full-text available via subscription   (Followers: 3, SJR: 0.344, CiteScore: 1)
Actas Urológicas Españolas (English Edition)     Full-text available via subscription   (Followers: 1)
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 7, SJR: 0.19, CiteScore: 0)
Actualites Pharmaceutiques Hospitalieres     Full-text available via subscription   (Followers: 3)
Acupuncture and Related Therapies     Hybrid Journal   (Followers: 8)
Acute Pain     Full-text available via subscription   (Followers: 15, SJR: 2.671, CiteScore: 5)
Ad Hoc Networks     Hybrid Journal   (Followers: 11, SJR: 0.53, CiteScore: 4)
Addictive Behaviors     Hybrid Journal   (Followers: 18, SJR: 1.29, CiteScore: 3)
Addictive Behaviors Reports     Open Access   (Followers: 9, SJR: 0.755, CiteScore: 2)
Additive Manufacturing     Hybrid Journal   (Followers: 11, SJR: 2.611, CiteScore: 8)
Additives for Polymers     Full-text available via subscription   (Followers: 23)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 184, SJR: 4.09, CiteScore: 13)
Advanced Engineering Informatics     Hybrid Journal   (Followers: 12, SJR: 1.167, CiteScore: 4)
Advanced Powder Technology     Hybrid Journal   (Followers: 17, SJR: 0.694, CiteScore: 3)
Advances in Accounting     Hybrid Journal   (Followers: 9, SJR: 0.277, CiteScore: 1)
Advances in Agronomy     Full-text available via subscription   (Followers: 17, SJR: 2.384, CiteScore: 5)
Advances in Anesthesia     Full-text available via subscription   (Followers: 29, SJR: 0.126, CiteScore: 0)
Advances in Antiviral Drug Design     Full-text available via subscription   (Followers: 2)
Advances in Applied Mathematics     Full-text available via subscription   (Followers: 11, SJR: 0.992, CiteScore: 1)
Advances in Applied Mechanics     Full-text available via subscription   (Followers: 11, SJR: 1.551, CiteScore: 4)
Advances in Applied Microbiology     Full-text available via subscription   (Followers: 24, SJR: 2.089, CiteScore: 5)
Advances In Atomic, Molecular, and Optical Physics     Full-text available via subscription   (Followers: 15, SJR: 0.572, CiteScore: 2)
Advances in Biological Regulation     Hybrid Journal   (Followers: 4, SJR: 2.61, CiteScore: 7)
Advances in Botanical Research     Full-text available via subscription   (Followers: 2, SJR: 0.686, CiteScore: 2)
Advances in Cancer Research     Full-text available via subscription   (Followers: 33, SJR: 3.043, CiteScore: 6)
Advances in Carbohydrate Chemistry and Biochemistry     Full-text available via subscription   (Followers: 9, SJR: 1.453, CiteScore: 2)
Advances in Catalysis     Full-text available via subscription   (Followers: 5, SJR: 1.992, CiteScore: 5)
Advances in Cell Aging and Gerontology     Full-text available via subscription   (Followers: 5)
Advances in Cellular and Molecular Biology of Membranes and Organelles     Full-text available via subscription   (Followers: 14)
Advances in Chemical Engineering     Full-text available via subscription   (Followers: 29, SJR: 0.156, CiteScore: 1)
Advances in Child Development and Behavior     Full-text available via subscription   (Followers: 10, SJR: 0.713, CiteScore: 1)
Advances in Chronic Kidney Disease     Full-text available via subscription   (Followers: 10, SJR: 1.316, CiteScore: 2)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 26, SJR: 1.562, CiteScore: 3)
Advances in Colloid and Interface Science     Full-text available via subscription   (Followers: 20, SJR: 1.977, CiteScore: 8)
Advances in Computers     Full-text available via subscription   (Followers: 14, SJR: 0.205, CiteScore: 1)
Advances in Dermatology     Full-text available via subscription   (Followers: 15)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 13)
Advances in Digestive Medicine     Open Access   (Followers: 12)
Advances in DNA Sequence-Specific Agents     Full-text available via subscription   (Followers: 7)
Advances in Drug Research     Full-text available via subscription   (Followers: 26)
Advances in Ecological Research     Full-text available via subscription   (Followers: 44, SJR: 2.524, CiteScore: 4)
Advances in Engineering Software     Hybrid Journal   (Followers: 29, SJR: 1.159, CiteScore: 4)
Advances in Experimental Biology     Full-text available via subscription   (Followers: 8)
Advances in Experimental Social Psychology     Full-text available via subscription   (Followers: 51, SJR: 5.39, CiteScore: 8)
Advances in Exploration Geophysics     Full-text available via subscription   (Followers: 1)
Advances in Fluorine Science     Full-text available via subscription   (Followers: 9)
Advances in Food and Nutrition Research     Full-text available via subscription   (Followers: 65, SJR: 0.591, CiteScore: 2)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 17)
Advances in Genetics     Full-text available via subscription   (Followers: 21, SJR: 1.354, CiteScore: 4)
Advances in Genome Biology     Full-text available via subscription   (Followers: 10, SJR: 12.74, CiteScore: 13)
Advances in Geophysics     Full-text available via subscription   (Followers: 7, SJR: 1.193, CiteScore: 3)
Advances in Heat Transfer     Full-text available via subscription   (Followers: 26, SJR: 0.368, CiteScore: 1)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 11, SJR: 0.749, CiteScore: 3)
Advances in Human Factors/Ergonomics     Full-text available via subscription   (Followers: 24)
Advances in Imaging and Electron Physics     Full-text available via subscription   (Followers: 3, SJR: 0.193, CiteScore: 0)
Advances in Immunology     Full-text available via subscription   (Followers: 36, SJR: 4.433, CiteScore: 6)
Advances in Inorganic Chemistry     Full-text available via subscription   (Followers: 10, SJR: 1.163, CiteScore: 2)
Advances in Insect Physiology     Full-text available via subscription   (Followers: 2, SJR: 1.938, CiteScore: 3)
Advances in Integrative Medicine     Hybrid Journal   (Followers: 6, SJR: 0.176, CiteScore: 0)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 3)
Advances in Life Course Research     Hybrid Journal   (Followers: 9, SJR: 0.682, CiteScore: 2)
Advances in Lipobiology     Full-text available via subscription   (Followers: 1)
Advances in Magnetic and Optical Resonance     Full-text available via subscription   (Followers: 8)
Advances in Marine Biology     Full-text available via subscription   (Followers: 21, SJR: 0.88, CiteScore: 2)
Advances in Mathematics     Full-text available via subscription   (Followers: 12, SJR: 3.027, CiteScore: 2)
Advances in Medical Sciences     Hybrid Journal   (Followers: 8, SJR: 0.694, CiteScore: 2)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 6)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 5, SJR: 1.158, CiteScore: 3)
Advances in Molecular and Cell Biology     Full-text available via subscription   (Followers: 24)
Advances in Molecular and Cellular Endocrinology     Full-text available via subscription   (Followers: 8)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 7, SJR: 0.182, CiteScore: 0)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 5)
Advances in Oncobiology     Full-text available via subscription   (Followers: 2)
Advances in Organ Biology     Full-text available via subscription   (Followers: 2)
Advances in Organometallic Chemistry     Full-text available via subscription   (Followers: 18, SJR: 1.875, CiteScore: 4)
Advances in Parallel Computing     Full-text available via subscription   (Followers: 7, SJR: 0.174, CiteScore: 0)
Advances in Parasitology     Full-text available via subscription   (Followers: 5, SJR: 1.579, CiteScore: 4)
Advances in Pediatrics     Full-text available via subscription   (Followers: 27, SJR: 0.461, CiteScore: 1)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 18)
Advances in Pharmacology     Full-text available via subscription   (Followers: 17, SJR: 1.536, CiteScore: 3)
Advances in Physical Organic Chemistry     Full-text available via subscription   (Followers: 9, SJR: 0.574, CiteScore: 1)
Advances in Phytomedicine     Full-text available via subscription  
Advances in Planar Lipid Bilayers and Liposomes     Full-text available via subscription   (Followers: 3, SJR: 0.109, CiteScore: 1)
Advances in Plant Biochemistry and Molecular Biology     Full-text available via subscription   (Followers: 10)
Advances in Plant Pathology     Full-text available via subscription   (Followers: 6)
Advances in Porous Media     Full-text available via subscription   (Followers: 5)
Advances in Protein Chemistry     Full-text available via subscription   (Followers: 19)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 20, SJR: 0.791, CiteScore: 2)
Advances in Psychology     Full-text available via subscription   (Followers: 66)
Advances in Quantum Chemistry     Full-text available via subscription   (Followers: 6, SJR: 0.371, CiteScore: 1)
Advances in Radiation Oncology     Open Access   (Followers: 1, SJR: 0.263, CiteScore: 1)
Advances in Small Animal Medicine and Surgery     Hybrid Journal   (Followers: 3, SJR: 0.101, CiteScore: 0)
Advances in Space Biology and Medicine     Full-text available via subscription   (Followers: 6)
Advances in Space Research     Full-text available via subscription   (Followers: 420, SJR: 0.569, CiteScore: 2)
Advances in Structural Biology     Full-text available via subscription   (Followers: 5)
Advances in Surgery     Full-text available via subscription   (Followers: 13, SJR: 0.555, CiteScore: 2)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 37, SJR: 2.208, CiteScore: 4)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 20)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 15)
Advances in Virus Research     Full-text available via subscription   (Followers: 6, SJR: 2.262, CiteScore: 5)
Advances in Water Resources     Hybrid Journal   (Followers: 53, SJR: 1.551, CiteScore: 3)
Aeolian Research     Hybrid Journal   (Followers: 6, SJR: 1.117, CiteScore: 3)
Aerospace Science and Technology     Hybrid Journal   (Followers: 382, SJR: 0.796, CiteScore: 3)
AEU - Intl. J. of Electronics and Communications     Hybrid Journal   (Followers: 8, SJR: 0.42, CiteScore: 2)
African J. of Emergency Medicine     Open Access   (Followers: 6, SJR: 0.296, CiteScore: 0)
Ageing Research Reviews     Hybrid Journal   (Followers: 12, SJR: 3.671, CiteScore: 9)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 474, SJR: 1.238, CiteScore: 3)
Agri Gene     Hybrid Journal   (Followers: 1, SJR: 0.13, CiteScore: 0)
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 18, SJR: 1.818, CiteScore: 5)
Agricultural Systems     Hybrid Journal   (Followers: 31, SJR: 1.156, CiteScore: 4)
Agricultural Water Management     Hybrid Journal   (Followers: 45, SJR: 1.272, CiteScore: 3)
Agriculture and Agricultural Science Procedia     Open Access   (Followers: 4)
Agriculture and Natural Resources     Open Access   (Followers: 3)
Agriculture, Ecosystems & Environment     Hybrid Journal   (Followers: 58, SJR: 1.747, CiteScore: 4)
Ain Shams Engineering J.     Open Access   (Followers: 5, SJR: 0.589, CiteScore: 3)
Air Medical J.     Hybrid Journal   (Followers: 7, SJR: 0.26, CiteScore: 0)
AKCE Intl. J. of Graphs and Combinatorics     Open Access   (SJR: 0.19, CiteScore: 0)
Alcohol     Hybrid Journal   (Followers: 12, SJR: 1.153, CiteScore: 3)
Alcoholism and Drug Addiction     Open Access   (Followers: 11)
Alergologia Polska : Polish J. of Allergology     Full-text available via subscription   (Followers: 1)
Alexandria Engineering J.     Open Access   (Followers: 2, SJR: 0.604, CiteScore: 3)
Alexandria J. of Medicine     Open Access   (Followers: 1, SJR: 0.191, CiteScore: 1)
Algal Research     Partially Free   (Followers: 11, SJR: 1.142, CiteScore: 4)
Alkaloids: Chemical and Biological Perspectives     Full-text available via subscription   (Followers: 2)
Allergologia et Immunopathologia     Full-text available via subscription   (Followers: 1, SJR: 0.504, CiteScore: 1)
Allergology Intl.     Open Access   (Followers: 5, SJR: 1.148, CiteScore: 2)
Alpha Omegan     Full-text available via subscription   (SJR: 3.521, CiteScore: 6)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 10, SJR: 0.201, CiteScore: 1)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 54, SJR: 4.66, CiteScore: 10)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 6, SJR: 1.796, CiteScore: 4)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 6, SJR: 1.108, CiteScore: 3)
Ambulatory Pediatrics     Hybrid Journal   (Followers: 5)
American Heart J.     Hybrid Journal   (Followers: 58, SJR: 3.267, CiteScore: 4)
American J. of Cardiology     Hybrid Journal   (Followers: 63, SJR: 1.93, CiteScore: 3)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 46, SJR: 0.604, CiteScore: 1)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 12)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 14, SJR: 1.524, CiteScore: 3)
American J. of Human Genetics     Hybrid Journal   (Followers: 37, SJR: 7.45, CiteScore: 8)
American J. of Infection Control     Hybrid Journal   (Followers: 29, SJR: 1.062, CiteScore: 2)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 36, SJR: 2.973, CiteScore: 4)
American J. of Medicine     Hybrid Journal   (Followers: 50)
American J. of Medicine Supplements     Full-text available via subscription   (Followers: 3, SJR: 1.967, CiteScore: 2)
American J. of Obstetrics and Gynecology     Hybrid Journal   (Followers: 249, SJR: 2.7, CiteScore: 4)
American J. of Ophthalmology     Hybrid Journal   (Followers: 66, SJR: 3.184, CiteScore: 4)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 5, SJR: 0.265, CiteScore: 0)
American J. of Orthodontics and Dentofacial Orthopedics     Full-text available via subscription   (Followers: 6, SJR: 1.289, CiteScore: 1)
American J. of Otolaryngology     Hybrid Journal   (Followers: 25, SJR: 0.59, CiteScore: 1)
American J. of Pathology     Hybrid Journal   (Followers: 32, SJR: 2.139, CiteScore: 4)
American J. of Preventive Medicine     Hybrid Journal   (Followers: 28, SJR: 2.164, CiteScore: 4)
American J. of Surgery     Hybrid Journal   (Followers: 39, SJR: 1.141, CiteScore: 2)
American J. of the Medical Sciences     Hybrid Journal   (Followers: 12, SJR: 0.767, CiteScore: 1)
Ampersand : An Intl. J. of General and Applied Linguistics     Open Access   (Followers: 7)
Anaerobe     Hybrid Journal   (Followers: 4, SJR: 1.144, CiteScore: 3)
Anaesthesia & Intensive Care Medicine     Full-text available via subscription   (Followers: 66, SJR: 0.138, CiteScore: 0)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 24, SJR: 0.411, CiteScore: 1)
Anales de Cirugia Vascular     Full-text available via subscription   (Followers: 1)
Anales de Pediatría     Full-text available via subscription   (Followers: 3, SJR: 0.277, CiteScore: 0)
Anales de Pediatría (English Edition)     Full-text available via subscription  
Anales de Pediatría Continuada     Full-text available via subscription  
Analytic Methods in Accident Research     Hybrid Journal   (Followers: 5, SJR: 4.849, CiteScore: 10)
Analytica Chimica Acta     Hybrid Journal   (Followers: 44, SJR: 1.512, CiteScore: 5)
Analytica Chimica Acta : X     Open Access  
Analytical Biochemistry     Hybrid Journal   (Followers: 210, SJR: 0.633, CiteScore: 2)
Analytical Chemistry Research     Open Access   (Followers: 13, SJR: 0.411, CiteScore: 2)
Analytical Spectroscopy Library     Full-text available via subscription   (Followers: 14)
Anesthésie & Réanimation     Full-text available via subscription   (Followers: 2)
Anesthesiology Clinics     Full-text available via subscription   (Followers: 25, SJR: 0.683, CiteScore: 2)
Angiología     Full-text available via subscription   (SJR: 0.121, CiteScore: 0)
Angiologia e Cirurgia Vascular     Open Access   (Followers: 1, SJR: 0.111, CiteScore: 0)
Animal Behaviour     Hybrid Journal   (Followers: 218, SJR: 1.58, CiteScore: 3)
Animal Feed Science and Technology     Hybrid Journal   (Followers: 6, SJR: 0.937, CiteScore: 2)
Animal Reproduction Science     Hybrid Journal   (Followers: 7, SJR: 0.704, CiteScore: 2)

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Similar Journals
Journal Cover
American Heart Journal
Journal Prestige (SJR): 3.267
Citation Impact (citeScore): 4
Number of Followers: 58  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
Published by Elsevier Homepage  [3184 journals]
  • Claims-based cardiovascular outcome identification for clinical research:
           Results from seven large randomized cardiovascular clinical trials
    • Abstract: Publication date: Available online 12 September 2019Source: American Heart JournalAuthor(s): J. Matthew Brennan, Lisa Wruck, Michael J. Pencina, Robert M. Clare, Renato D. Lopes, John H. Alexander, Sean O'Brien, Mitchell Krucoff, Sunil V. Rao, Tracy Y. Wang, Lesley H. Curtis, L. Kristin Newby, Christopher B. Granger, Manesh Patel, Kenneth Mahaffey, Joseph S. Ross, Sharon-Lise Normand, Benjamin C. Eloff, Daniel A. Caños, Yuliya V. Lokhnygina BackgroundMedicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- vs. site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes.MethodsWe performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from seven randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage.Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the two. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection.ResultsAmong the 5839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted kappa 0.99), MI (2.2% vs. 2.3%; adjusted kappa 0.96), stroke (0.7% vs. 0.7%; adjusted kappa 0.99), any revascularization (7.4% vs. 7.9%; adjusted kappa 0.95). Of events detected by claims, yet not reported by CEC, a minority were reported by sites, but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the three approaches for each outcome of interest.ConclusionsClaims- vs. site-based (+CEC) follow-up identified similar overall cardiovascular event rates, despite meaningful differences in the events detected. Randomized treatment effects were similar using the two methods, suggesting claims data could be used to support clinical research leveraging routinely-collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.
       
  • ISCHEMIA Trial Update.
    • Abstract: Publication date: Available online 11 September 2019Source: American Heart JournalAuthor(s): John Spertus, Daniel Mark
       
  • Grenada heart project- community health ActioN to EncouraGe healthy
           BEhaviors (GHP–CHANGE): A randomized control peer group based lifestyle
           intervention
    • Abstract: Publication date: Available online 4 September 2019Source: American Heart JournalAuthor(s): Jacqueline Latina, Rodrigo Fernandez-Jimenez, Sameer Bansilal, Samantha Sartori, Rajesh Vedanthan, Marcelle Lewis, Claire Kofler, Marilyn Hunn, Francis Martin, Emilia Bagiella, Michael Farkouh, Valentin Fuster BackgroundThe incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs.AimThe Grenada Heart Project- Community Health ActioN to EncouraGe Healthy BEhaviors (GHP-CHANGE) was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC.MethodsWe recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects.ResultsParticipants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: −0.12 to 0.75; P = .154).ConclusionsThe GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs.
       
  • Income level and inequality as complement to geographical differences in
           cardiovascular trials
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): João Pedro Ferreira, Patrick Rossignol, Pooja Dewan, Zohra Lamiral, William B. White, Bertram Pitt, John J.V. McMurray, Faiez Zannad BackgroundAnalyses of country or regional differences in cardiovascular (CV) trials are based on geographical subgroup analyses. However, apart from map location, and related racial, ethnic and genetic variations, identified differences may also depend on social structure and provision and access to health care, for which country income and income-inequality are indicators.AimsTo study the association between country per capita income and income-inequality and prognosis in patients with heart failure (HF) or an acute coronary syndrome (ACS) in three international trials (EMPHASIS-HF, EPHESUS, and EXAMINE).MethodsCountries were classified into high-income or low-middle income (LMICs) and in low, middle, or high inequality using the Gini index. The main outcome measures were all-cause and cardiovascular death.ResultsPatients from LMICs and countries with higher inequality were younger, less often white, had fewer co-morbid conditions, and were less often treated with guideline-recommended therapies, including devices. These patients had higher adjusted mortality rates (+15% to +70%) compared with patients from high-income countries and countries with less inequality. Patients from countries with the combination of greater inequality and low-middle income had particularly high mortality rates (+80% to +190%) compared with those that did not have both characteristics. Living in a poor and inequal country had more impact on death rates than any co-morbidity. These findings were reproduced in 3 trials.ConclusionPatients from LMICs and countries with greater inequality had the highest mortality rates. The prognostic impact of income and inequality is substantial and should be considered when looking into subgroup differences in cardiovascular trials.
       
  • Clinical research study implementation of case-finding strategies for
           heart failure and chronic obstructive pulmonary disease in the elderly
           with reduced exercise tolerance or dyspnoea: A cluster randomized trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Yvonne van Mourik, Frans H. Rutten, Loes C.M. Bertens, Maarten J.M. Cramer, Jan-Willem J. Lammers, Aisha Gohar, Johannes B. Reitsma, Karel G.M. Moons, Arno W. Hoes BackgroundHeart failure (HF) and chronic obstructive pulmonary disease (COPD) often remain undiagnosed in older individuals, while both disorders inhibit functionality and impair health.AimTo assess the effectiveness of a case-finding strategy of these disorders.Design and settingClustered randomized trial; eighteen general practices from the vicinity of Utrecht, the Netherlands, were randomly allocated to a case-finding strategy or usual care.MethodsMultimorbid community subjects (≥65 years) with dyspnoea or reduced exercise tolerance were eligible for inclusion. The case-finding strategy consisted of history taking, physical examination, blood tests, electrocardiography, spirometry and echocardiography. Subsequent treatment decisions were at the discretion of the general practitioner. Questionnaires regarding health status and functionality were filled out at baseline and after six months of follow-up. Information regarding changes in medication and health care use during the six months follow-up was extracted.Results829 participants were randomized; 389 in the case-finding strategy group and 440 in the usual care group. More patients in the case-finding group received a new diagnosis of HF or COPD than the usual care group (cumulative incidence 34% vs. 2%, and 17% vs. 2%, respectively). Scores for health status, functionality, and health care use were similar between the two strategies after six months of follow-up.ConclusionA case-finding strategy applied in primary care to multimorbid older people with dyspnoea or reduced exercise tolerance resulted in a number of new diagnoses of HF and COPD, but did not result in short-term improvement of health status compared to usual care.Trial registration.ClinicalTrials.gov NCT01148719
       
  • Distal evaluation of functional performance with intravascular sensors to
           assess the narrowing effect – Combined pressure and Doppler FLOW
           velocity measurements (DEFINE-FLOW) trial: Rationale and trial design
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Valérie E. Stegehuis, Gilbert W.M. Wijntjens, Tim P. van de Hoef, Lorena Casadonte, Richard L. Kirkeeide, Maria Siebes, Jos A.E. Spaan, K. Lance Gould, Nils P. Johnson, Jan J. Piek BackgroundIt remains uncertain if invasive coronary physiology beyond fractional flow reserve (FFR) can refine lesion selection for revascularization or provide additional prognostic value. Coronary flow reserve (CFR) equals the ratio of hyperemic to baseline flow velocity and has a wealth of invasive and non-invasive data supporting its validity. Due to fundamental physiologic relationships, binary classification of FFR and CFR disagree in approximately 30–40% of cases. Optimal management of these discordant cases requires further study.AimTo determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of major adverse cardiac events (MACE). Secondary endpoints include repeatability of FFR and CFR, angina burden, and the percentage of successful FFR/CFR measurements which will not be excluded by the corelab.MethodsThis prospective, non-blinded, non-randomized, and multi-center study enrolled 455 subjects from 12 sites in Europe and Japan. Patients underwent physiologic lesion assessment using the 0.014” Philips Volcano ComboWire XT that provides simultaneous pressure and Doppler velocity sensors. Intermediate coronary lesions received only medical treatment unless both FFR (≤0.8) and CFR ( 0.80 and CFR ≥ 2.0. Enrollment has been completed and final follow-up will occur in November 2019.
       
  • Variations in stepped-wedge cluster randomized trial design: Insights from
           the ‘patient-centered care transitions in heart failure’ trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Rudy R. Unni, Shun Fu Lee, Lehana Thabane, Stuart Connolly, Harriette GC Van Spall The stepped-wedge (SW) cluster randomized controlled trial (RCT), in which clusters cross over in a randomized sequence from control to intervention is ideal for the implementation and testing of complex health service interventions. In certain cases, however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required.We examine the logistical and statistical implications of variations in SW design, using the optimization of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) trial for illustration. We review the following complete SW design variations: a typical SW design; a SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested sub-studies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed three incomplete SW design variations in which data is collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness.Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of a SW RCT.
       
  • Ticagrelor-based antiplatelet regimens in patients with atherosclerotic
           artery disease - a meta-analysis of randomized clinical trials
    • Abstract: Publication date: Available online 31 August 2019Source: American Heart JournalAuthor(s): Salvatore Cassese, Gjin Ndrepepa, Robert A. Byrne, Karl-Ludwig Laugwitz, Heribert Schunkert, Massimiliano Fusaro, Fernando Alfonso, Adnan Kastrati BackgroundRandomized trials did not consistently support superiority of ticagrelor, as monotherapy or in combination with aspirin, in terms of efficacy or safety, in patients with atherosclerotic artery disease.MethodsMedline, EMBASE, the Cochrane Central Register of Controlled Trials and scientific session abstracts were searched for trials of patients with coronary or peripheral artery disease (with>1000 participants and a follow-up ≥3 months) randomly assigned to ticagrelor-based or conventional antiplatelet therapies. Trial-level hazard ratios were pooled using a fixed or random effect model (in case of significant heterogeneity) with the inverse variance weighting. The primary outcome was all-cause mortality. Other outcomes were myocardial infarction (MI), stroke and major bleeding.ResultsOverall 77,489 patients received either ticagrelor-based (n = 38,721) or conventional antiplatelet regimens (n = 38,768) in six trials. The primary outcome occurred in 4.5% of patients treated with experimental therapy and 4.9% of patients treated with control therapy (hazard ratio [HR] = 0.91, 95% confidence interval [CI] 0.81 to 1.01; P = .07). Overall, patients treated with ticagrelor-based versus conventional antiplatelet regimens showed no significant difference in terms of all-cause death, MI, stroke or major bleeding after 20 months. However, in trials of patients with coronary artery disease (CAD) as primary diagnosis, the risk for all-cause death (HR = 0.84 [0.77–0.91], P 
       
  • International variation in characteristics and clinical outcomes of
           patients with type 2 diabetes and heart failure: Insights from TECOS
    • Abstract: Publication date: Available online 28 August 2019Source: American Heart JournalAuthor(s): Ankeet S. Bhatt, Nancy Luo, Nicole Solomon, Neha J. Pagidipati, Giuseppe Ambrosio, Jennifer B. Green, Darren K. McGuire, Eberhard Standl, Jan H Cornel, Sigrun Halvorsen, Renato D. Lopes, Harvey D. White, Rury R. Holman, Eric D. Peterson, Robert J. Mentz, TECOS Study Group BackgroundInternational differences in management/outcomes among patients with type 2 diabetes (T2D) and heart failure (HF) are not well-characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients.Methods and ResultsAmong 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF
       
  • Hybrid comprehensive telerehabilitation in heart failure patients
           (TELEREH-HF) - a randomized, multi-center, prospective, open-label,
           parallel group controlled trial - study design and description of the
           intervention
    • Abstract: Publication date: Available online 22 August 2019Source: American Heart JournalAuthor(s): Ewa Piotrowicz, Ryszard Piotrowicz, Grzegorz Opolski, Michael Pencina, Maciej Banach, Wojciech Zaręba BackgroundGuidelines recommend exercise training as a component of heart failure (HF) management. There are large disparities in access to rehabilitation and introducing hybrid comprehensive telerehabilitation (TR) consisting of remote monitoring of training in patients' homes might be an optimal solution in Poland.PurposeThe primary objective of the TELEREH-HF trial is to determine whether introducing TR will significantly increase days alive and out of hospital compared with usual care. The secondary objectives including assessment the effects of TR compared to usual care on all-cause and cardiovascular mortality and all-cause, cardiovascular and HF hospitalization. The tertiary analyses include: evaluation of the safety, effectiveness, quality of life, depression, anxiety, patients' acceptance of and adherence to TR.MethodsThe TELEREH-HF study is a randomized, multi-center, prospective, open-label, parallel group controlled trial in 850 HF patients after a hospitalization incident in NYHA I-III and LVEF≤40%. Patients were randomized to TR + usual care (TR group) or to usual care only (control group) and are followed for a maximum of 24 months. The TR group patients underwent a 9-week TR program consisting of an initial stage (1 week) conducted at hospital and a basic stage (8-week) home-based TR five times weekly.ResultsAll patients were randomized and completed initial intervention in the TR group. The follow up of both groups is in progress.ConclusionThe TELEREH-HF trial will provide novel data on the effects of telerhabilitation on hospitalization and mortality in HF patients, and on safety, qaulity of life, depression, anxiety and acceptance of and adherence to this intervention.
       
  • Long-Term (10-Year) Outcomes of Stenting or Bypass Surgery for Acute
           Coronary Syndromes and Stable Ischemic Heart Disease With Unprotected Left
           Main Coronary Artery Disease
    • Abstract: Publication date: Available online 20 August 2019Source: American Heart JournalAuthor(s): Sangwoo Park, Jung-Min Ahn, Kyusup Lee, Osung Kwon, Hanbit Park, Yong-Hoon Yoon, Do-Yoon Kang, Pil Hyung Lee, Seung-Whan Lee, Seong-Wook Park, Duk-Woo Park, Seung-Jung Park BackgroundAcuity of clinical presentation may influence decision-making of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. However, it is undetermined whether clinical indication for myocardial revascularization may affect the relative long-term effect after PCI and CABG.MethodsIn the MAIN-COMPARE study including 2240 patients with LMCA disease treated with PCI (n = 1102) or CABG (n = 1138), we examined interaction between acuity of clinical presentation (acute coronary syndromes [ACS] or non-ACS) and revascularization strategy on 10-year outcomes. Primary outcome was a composite of all-cause death, Q-wave myocardial infarction (MI), or stroke. Secondary outcomes were all-cause death or target-vessel revascularization (TVR).ResultsIn overall patients, 1,603 patients (71.6%) presented with ACS and 637 patients (28.4%) presented with non-ACS. The 10-year adjusted risks for primary composite outcome were similar after PCI and CABG among patients presented with non-ACS (hazard ratio [HR] 1.07; 95% confidence interval [CI] 0.71–1.61) and those presented with ACS (HR 1.00; 95% CI 0.81–1.24) (P-for-interaction=0.29). The adjusted risks of death were also similar between 2 groups in non-ACS (HR 0.98; 95% CI 0.63–1.51) and ACS (HR 1.02; 95% CI 0.81–1.28) patients (P-for-interaction=0.62). The adjusted risks of TVR were consistently higher after PCI in in non-ACS (HR 6.38; 95% CI 3.14–12.96) and ACS (HR 3.96; 95% CI 2.80–5.60) patients (P-for-interaction=0.39).ConclusionsIn patients with LMCA disease, we have identified no significant interaction between the acuity of clinical indication and the relative treatment effect of PCI versus CABG on 10-year clinical outcomes.
       
  • Erratum to “Increased hepatocyte growth factor levels over 2 years are
           associated with coronary heart disease: The Multi-Ethnic Study of
           Atherosclerosis (MESA)” [Am Heart J (2019) 30–34]
    • Abstract: Publication date: Available online 20 August 2019Source: American Heart JournalAuthor(s): Paul A. Decker, Nicholas B. Larson, Elizabeth J. Bell, James S. Pankow, Naomi Q. Hanson, Christina L. Wassel, Michael Y. Tsai, Suzette J. Bielinski
       
  • Association of 25-hydroxyvitamin D with incident coronary heart disease in
           the reasons for geographic and racial differences in stroke (REGARDS)
           study
    • Abstract: Publication date: Available online 19 August 2019Source: American Heart JournalAuthor(s): Shejuti Paul, Suzanne E. Judd, Virginia J. Howard, Monika S. Safford, Orlando M. Gutiérrez BackgroundLow circulating 25-hydroxyvitamin D (25(OH)D) has been associated with increased risk of coronary heart disease (CHD), but whether this association differs by race is unclear.MethodsWe examined the association of 25(OH)D with incident CHD in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, a prospective cohort study of black and white adults ≥45 years of age enrolled between 2003 and 2007 with follow-up through December 31, 2011. Using a case-cohort design, we measured 25(OH)D in 829 participants who developed incident CHD (cases) and in 813 participants without CHD randomly selected from the REGARDS cohort (comparison sub-cohort). Cox proportional hazards models were used to examine associations of 25(OH)D with incident CHD adjusting for established CHD risk factors in the study sample overall and stratified by race.ResultsIn the fully adjusted model, lower quintiles of 25(OH)D were associated with a greater risk of incident CHD (25(OH)D > 33.6 ng/ml reference; 25(OH)D > 27.1–33.6 ng/ml, HR 2.79, 95%CI 1.64,4.76; 25(OH)D > 22.4–27.1 ng/ml, HR 2.77, 95%CI 1.57,4.89; 25(OH)D > 16.5–22.4 ng/ml, HR 5.52, 95%CI 3.21,9.50; 25(OH)D ≤ 16.5 ng/ml, HR 7.46, 95%CI 4.19,13.25). The results were similar when 25(OH)D was examined on a continuous scale (HR per 10 ng/ml decrement in 25(OH)D 2.04, 95%CI 1.65,2.52). The results did not statistically differ by race whether 25(OH)D was examined as a categorical or continuous variable (Pinteraction> 0.10).ConclusionsLower plasma 25(OH)D concentrations were associated with higher risk of incident CHD. In contrast to prior studies, these associations did not differ by race.
       
  • The subcutaneous implantable cardioverter-defibrillator in review
    • Abstract: Publication date: Available online 17 August 2019Source: American Heart JournalAuthor(s): Nicholas J Kamp, Sana M Al-Khatib The subcutaneous implantable cardioverter defibrillator (S-ICD) is a completely extrathoracic device that has recently been FDA approved for the prevention of sudden cardiac death in select populations. Although the transvenous implantable cardioverter defibrillator (TV-ICD) has a proven mortality benefit in multiple patient populations, there are significant risks both with implantation and years after its placement. The S-ICD may help prevent some of these complications. Currently, the S-ICD is typically implanted in patients with prior device infection or at an increased risk for an infection, younger patients with difficult venous access related to either hemodialysis or difficult cardiac anatomy, patients who live active lifestyles, and those who may outlive the TV-ICD leads. There is an absolute contraindication for S-ICD implantations for patients who need pacing either for ventricular tachycardia or bradycardia as this device cannot perform these functions. To date, there are no randomized controlled trial data evaluating the safety and efficacy of this relatively new device. Observational studies of both the S-ICD alone and in comparison with the TV-ICD have showed promising results, including a decrease in lead related and periprocedural complications as well as a high level of effectiveness at terminating ventricular arrhythmias. These analyses overtime may have contributed to the evolution and comfortability with the S-ICD system as physicians are more often referring for and/or implanting this device for patients with appropriate indications. Furthermore, inappropriate shock rates with the S-ICD have decreased overtime especially with dual zone programming. This review summarizes the results of a multitude of observational studies with respect to patient selection for the S-ICD, complication rates, appropriate and inappropriate shock rates, and programming. This review also tackles current ongoing randomized trials. Although the results of ongoing trials will be helpful, there is still a continued need to evaluate the efficacy of the S-ICD in broader patient populations including patients with several comorbidities and older patients so that more patients can be considered for this potentially lifesaving device.
       
  • Sudden cardiac death in patients with Myocarditis: Evaluation, risk
           stratification, and management
    • Abstract: Publication date: Available online 15 August 2019Source: American Heart JournalAuthor(s): Fatima Ali-Ahmed, Frederik Dalgaard, Sana M. Al-Khatib Myocarditis is a major cause of sudden cardiac death (SCD) and dilated cardiomyopathy (DCM) in young adults. Cardiac magnetic resonance (CMR) is the established tool for the diagnosis of myocarditis, and late gadolinium enhancement (LGE) detected on CMR imaging is the strongest independent predictor of SCD, all-cause mortality, and cardiac mortality. Several other factors have been associated with SCD or cardiac transplantation including New York Heart Association functional class III/IV, reduced left ventricular ejection fraction (LVEF)
       
  • Comparison of the cardiovascular benefits of resistance, aerobic, and
           combined exercise (CardioRACE): Rationale, design, and methods
    • Abstract: Publication date: Available online 15 August 2019Source: American Heart JournalAuthor(s): Angelique G. Brellenthin, Lorraine M. Lanningham-Foster, Marian L. Kohut, Yehua Li, Timothy S. Church, Steven N. Blair, Duck-chul Lee BackgroundThe benefits of aerobic exercise (AE) for cardiovascular disease (CVD) have been well documented. Resistance exercise (RE) has been traditionally examined for its effects on bone density, physical function, or metabolic health, yet few data exist regarding the benefits of RE, independent of and combined with AE, for CVD prevention. This randomized controlled trial, “Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE),” is designed to determine the relative benefits of RE, AE, or combined RE plus AE training on CVD risk factors.MethodsParticipants are 406 inactive men and women (35–70 years) with a body mass index of 25–40 kg/m2 and blood pressure (BP) of 120–139/80–89 mmHg without taking antihypertensive medications. Participants are randomly assigned to RE only, AE only, combined RE and AE (CE), or a no exercise control group. Participants perform supervised exercise at 50%–80% of their relative maximum intensity for both AE and RE, 3 times/week for 60 minutes/session for 1 year (all 3 groups are time-matched).ResultsThe primary outcome is a composite z-score including resting BP, low-density lipoprotein cholesterol (LDL-C), fasting glucose, and percent body fat, which is assessed at baseline, 6-months, and 12-months. Diet and outside physical activity are measured throughout the intervention for 1 year.ConclusionCardioRACE (ClinicalTrials.gov NCT03069092) will fill an important knowledge gap regarding the effects of RE, alone or in addition to, the well-documented effects of AE. CardioRACE will help generate more comprehensive and synergistic clinical and public health strategies to prevent CVD.
       
  • Small for Gestational Age birth is linked to cardiovascular dysfunction in
           early childhood
    • Abstract: Publication date: Available online 13 August 2019Source: American Heart JournalAuthor(s): Matteo Castagno, Veronica Menegon, Alice Monzani, Sara Zanetta, Gioel Gabrio Secco, Roberta Rosso, Marco Binotti, Luigi Maiuri, Carlo Di Mario, Diego Gazzolo, Federica Ferrero, Giulia Genoni BackgroundAim of this study was to assess clinical and echographic markers of cardiovascular dysfunction in infants born small for gestational age (SGA), compared to a control group of subjects born adequate for gestational age (AGA).MethodsThis was a single-center cross-sectional case-control study. We recruited 20 SGA and 20 gestational age-matched AGA subjects at 24 months of age.The study population underwent anthropometric, Doppler two-dimensional echocardiographic assessments, carotid artery intima-media thickness (cIMT) and endothelium-dependent vasodilation evaluation (FMD).The pressure-volume curve during diastole was calculated using the algorithm for the elastance calculation on one single beat.ResultsSGA children showed lower stroke volume, left ventricle (LV) dimensions and volume, and greater LV thickness. Diastolic function was impaired in SGA with lower capacitance, and higher elastance.Birth weight standard deviation score (SDS) was positively associated with capacitance, and negatively with E/E’ ratio and elastance and in SGA infants the End Diastolic Pressure Related Volume (EDPRV) curve was shifted to the left compared to AGA.cIMT and systemic vascular resistance were significantly higher while FMD was lower in SGA compared to AGA; birth weight-SDS was directly correlated with FMD and inversely with cIMT.Finally, a longer breastfeeding duration was associated to a lower cIMT, even after correction for confounding factors.ConclusionsThis study shows that infants born SGA present an early and subtle cardiovascular dysfunction compared to AGA controls. These alterations are strongly related to weight at birth. Finally, breastfeeding exerts an important protective and beneficial cardiovascular effect.
       
  • C-reactive Protein and Stroke Risk in Blacks and Whites: the REasons for
           Geographic and Racial Differences in Stroke Cohort
    • Abstract: Publication date: Available online 12 August 2019Source: American Heart JournalAuthor(s): Christina R. Evans, D. Leann Long, George Howard, Leslie A. McClure, Neil A. Zakai, Nancy S. Jenny, Brett M. Kissela, Monika M. Safford, Virginia J. Howard, Mary Cushman BackgroundC-reactive protein (CRP) is an inflammatory biomarker used in vascular risk prediction, though with less data in non-white populations. Blacks have higher stroke incidence and also higher CRP than whites. We studied the association of CRP on ischemic stroke risk in blacks and whites.MethodsREGARDS, an observational cohort study, recruited and followed 30,239 black and white Americans aged 45 and older for ischemic stroke. We calculated hazard ratios (HR) and 95% confidence intervals of ischemic stroke by CRP category (10 mg/L, while in blacks an association was only seen for CRP>10 mg/L. Considered as a continuous variable, the the risk factor-adjusted HRs per SD higher lnCRP were 1.18 (95% CI 1.09 - 1.28) overall, 1.14 (95% CI 1.00 - 1.29) in blacks and 1.22 (95% CI 1.10 - 1.35) in whites. Spline regression analysis visually confirmed the race difference in the association.ConclusionsCRP may not be equally useful in stroke risk assessment in blacks and whites. Confirmation, similar study for coronary heart disease, and identification of reasons for these racial differences require further study.
       
  • Effect of selective BET protein inhibitor apabetalone on cardiovascular
           outcomes in patients with acute coronary syndrome and diabetes: Rationale,
           design, and baseline characteristics of the BETonMACE trial
    • Abstract: Publication date: Available online 9 August 2019Source: American Heart JournalAuthor(s): Kausik K. Ray, Stephen J. Nicholls, Henry Ginsberg, Jan O. Johansson, Kamyar Kalantar-Zadeh, Ewelina Kulikowski, Peter P. Toth, Norman Wong, Jeffrey L. Cummings, Michael Sweeney, Gregory G. Schwartz BackgroundAfter an acute coronary syndrome (ACS), patients with diabetes remain at high risk for additional cardiovascular events despite use of current therapies. Bromodomain and extra-terminal (BET) proteins are epigenetic modulators of inflammation, thrombogenesis, and lipoprotein metabolism implicated in atherothrombosis. The BETonMACE trial tests the hypothesis that treatment with apabetalone, a selective BET protein inhibitor, will improve cardiovascular outcomes in patients with diabetes after an ACS.DesignPatients (n = 2425) with ACS in the preceding 7–90 days, with type 2 diabetes and low HDL cholesterol (≤40 mg/dl for men, ≤45 mg/dl for women), receiving intensive or maximum-tolerated therapy with atorvastatin or rosuvastatin, were assigned in double-blind fashion to receive apabetalone 100 mg orally twice daily or matching placebo. Baseline characteristics include female sex (25%), myocardial infarction as index ACS event (74%), coronary revascularization for index ACS (76%), treatment with dual anti-platelet therapy (87%) and renin-angiotensin system inhibitors (91%), median LDL cholesterol 65 mg per deciliter, and median HbA1c 7.3%. The primary efficacy measure is time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or stroke. Assumptions include a primary event rate of 7% per annum in the placebo group and median follow-up of 1.5 years. Patients will be followed until at least 250 primary endpoint events have occurred, providing 80% power to detect a 30% reduction in the primary endpoint with apabetalone.SummaryBETonMACE will determine whether the addition of the selective BET protein inhibitor apabetalone to contemporary standard of care for ACS reduces cardiovascular morbidity and mortality in patients with type 2 diabetes. Results are expected in 2019.
       
  • Standardized Outcomes in Reproductive Cardiovascular Care: The STORCC
           Initiative
    • Abstract: Publication date: Available online 9 August 2019Source: American Heart JournalAuthor(s): Anne Marie Valente, Michael J. Landzberg, Kimberlee Gauvreau, Gabriele Egidy-Assenza, Nancy Barker, Sarah Partington, Roisin B. Morgan, Amy J. Harmon, Kelsey Hickey, Mary P. Mullen, Jean Marie Carabuena, Patrick O’Gara, Katherine E. Economy, on behalf of the STORCC Investigators BackgroundValidated protocols for diagnostic testing and management of pregnant women with cardiovascular disease (CVD) do not exist. Our objective was to establish a prospective standardized protocol for the clinical evaluation of pregnant women with CVD.Methods and ResultsThe Standardized Outcomes in Reproductive Cardiovascular Care (STORCC) initiative prospectively enrolled pregnant women with CVD into a standardized diagnostic testing and assessment protocol. Detailed cardiac and obstetric data were collected during the antepartum, intrapartum and postpartum periods. Each woman was assigned a STORCC color code of perceived risk at a monthly multidisciplinary conference. In 250 pregnancies of 207 women with CVD, the standardized care protocol was followed in 136 and routine care in 114. The median age of the subjects was 32 years, and the most common form of heart disease was congenital heart disease (77%). Women enrolled in standardized care protocol had high compliance with 2nd and 3rd trimester visits (93%) and post-partum visits (76%). Maternal cardiac complications occurred in 10%. The STORCC cardiac and obstetric color codes predicted adverse outcomes within each respective category (p = 0.02, 0.01).ConclusionsThe STORCC protocol for prospective diagnostic testing and follow-up of pregnant women with CVD was successfully established and compliance was high. The strength of a standardized testing and care protocol as well as detailed classification of labor and delivery characteristics allow for robust analyses into specific questions regarding testing protocols, and mode and timing of delivery.
       
  • A Multi-National Trial of a Direct Oral Anticoagulant in Children with
           Cardiac Disease: Design and Rationale of the SAXOPHONE Study
    • Abstract: Publication date: Available online 9 August 2019Source: American Heart JournalAuthor(s): R. Mark Payne, Kristin M. Burns, Andrew C Glatz, Danshi Li, Xiaodong Li, Paul Monagle, Jane W. Newburger, Elizabeth A. Swan, Olivia Wheaton, Christoph Male, Pediatric Heart Network Investigators Anticoagulation in children is problematic for multiple reasons. Currently used anticoagulants have significant disadvantages and may negatively affect quality of life (QOL). This manuscript describes the design, rationale, and methods of a prospective, randomized, open label phase II multi-national clinical trial of a direct oral anticoagulant (DOAC), apixaban, in children and infants with congenital and acquired heart disease. This trial is designed to gather preliminary safety and pharmacokinetics (PK) data, as well as generate data on QOL of individuals taking apixaban compared to the standard of care (SOC) anticoagulants vitamin K antagonists (VKA) or low molecular weight heparin (LMWH).A key issue this trial seeks to address is the practice of using therapeutics tested in adult trials in the pediatric population without robust pediatric safety or efficacy data. Pediatric heart diseases are not common, and specific diagnoses often meet the criteria of a rare disease; thus, statistical efficacy may be difficult to achieve. This trial will provide valuable PK and safety data intended to inform clinical practice for anticoagulation in pediatric heart diseases, a setting in which a fully powered phase III clinical trial is not feasible.A second consideration this trial addresses is that metrics besides efficacy, such as QOL, have not been traditionally used as endpoints in regulated anticoagulation studies yet may add substantial weight to the clinical decision for use of a DOAC in place of VKA or LMWH. This study examines QOL related to both heart disease and anticoagulation among children randomized to either SOC or apixaban.There are considerable strengths and benefits to conducting a clinical trial in pediatric rare disease populations via an industry-academic collaboration. The SAXOPHONE study represents a collaboration between Bristol-Myers Squibb (BMS)/Pfizer Alliance, and the National Heart, Lung, and Blood Institute’s (NHLBI) Pediatric Heart Network (PHN) and may be an attractive model for future pediatric drug trials.
       
  • Abnormal glucose metabolism in patients with Fontan circulation: Unique
           characteristics and associations with Fontan pathophysiology
    • Abstract: Publication date: Available online 26 July 2019Source: American Heart JournalAuthor(s): Hideo Ohuchi, Jun Negishi, Yosuke Hayama, Hikari Miike, Dai Suzuki, Kimiko Nakajima, Nao Konagai, Toru Iwasa, Heima Sakaguchi, Kenichi Kurosaki, Michikazu Nakai BackgroundFontan patients exhibit a high prevalence of abnormal glucose metabolism (AGM).PurposeWe aimed to characterize AGM and clarify its association with Fontan pathophysiology.Method and ResultsWe prospectively evaluated AGM with plasma glucose dynamics [mg/dL; fasting glucose (FPG), and maximum glucose increase (PG-spike)] during oral glucose tolerance test (OGTT) and hemoglobin A1c (HbA1c) in 276 consecutive Fontan patients (aged 19 ± 7 years). Of these, 176 patients had serial AGM assessments with a mean interval of 6.5 years. Initial analysis revealed a high prevalence of impaired glucose tolerance (38.4%) and diabetes mellitus (DM) (4.7%), and positive family history, high HbA1c, and high central venous pressure independently predicted presence of DM. HbA1c was independently determined by hypersplenism and presence of DM (P 
       
  • Surgical timing in infective endocarditis complicated by intracranial
           hemorrhage
    • Abstract: Publication date: Available online 23 July 2019Source: American Heart JournalAuthor(s): Rachael A. Venn, MingMing Ning, Gus J. Vlahakes, Jason H. Wasfy Given the growing incidence of infective endocarditis (IE), understanding the risks and benefits of valvular surgery is critical. This decision is particularly complex for the 1 in 10 cases complicated by intracranial hemorrhage (ICH). While guideline recommendations currently favor early surgery in general, delayed intervention of at least 4 weeks is still recommended for patients with ICH. To date, there are no randomized controlled trials that inform management of patients with an indication for surgery but concomitant ICH, and even reported observational data are rare. This paper reviews the current literature on timing of surgery with a specific focus on cases of ICH. It emphasizes a growing body of literature challenging the current paradigm that surgery within 4 weeks is associated with neurologic deterioration and high mortality rates by demonstrating favorable outcomes for patients with pre-operative ICH who undergo early valvular surgery. Based on these data, we propose a practical management algorithm to facilitate decisions on surgical timing in these complicated cases. Since more rigorous evidence may never be available, clinicians should make patient-specific surgical timing decisions that attempt to balance the competing risks of neurologic versus cardiac complications.
       
  • Reliable in Vivo intravascular imaging plaque characterization: A
           challenge unmet
    • Abstract: Publication date: Available online 23 July 2019Source: American Heart JournalAuthor(s): Anantharaman Ramasamy, Patrick W. Serruys, Daniel A. Jones, Thomas W. Johnson, Ryo Torii, Sean P. Madden, Rajiv Amersey, Rob Krams, Andreas Baumbach, Anthony Mathur, Christos V. Bourantas Intravascular imaging has enabled in vivo assessment of coronary artery pathology and detection of plaque characteristics that are associated with increased vulnerability. Prospective invasive imaging studies of coronary atherosclerosis have demonstrated that invasive imaging modalities can detect lesions that are likely to progress and cause cardiovascular events and provided unique insights about atherosclerotic evolution. However, despite the undoubted value of the existing imaging techniques in clinical and research arenas, all the available modalities have significant limitations in assessing plaque characteristics when compared with histology. Hybrid/multimodality intravascular imaging appears able to overcome some of the limitations of standalone imaging, however there are only few histology studies that examined their performance in evaluating plaque patho-biology. In this article, we review the evidence about the efficacy of standalone and multi-modality/hybrid intravascular imaging in assessing plaque morphology against histology, highlight the advantages and limitations of the existing imaging techniques and discuss the future potential of emerging imaging modalities in the study of atherosclerosis.
       
  • Risks of non-cardiac surgery early after percutaneous coronary
           intervention
    • Abstract: Publication date: Available online 22 July 2019Source: American Heart JournalAuthor(s): Nathaniel R. Smilowitz, Jeffrey Lorin, Jeffrey S. Berger BackgroundPrior registry data suggest that 4–20% of patients require non-cardiac surgery (NCS) within 2 years of percutaneous coronary intervention (PCI). Contemporary data on NCS after PCI in the United States among women and men are limited. We determined the rate of early hospital readmission for NCS and associated outcomes in a large cohort of patients who underwent PCI in the United States.MethodsAdults undergoing PCI between January 1st and June 30th, 2014 were identified from the Nationwide Readmission Database. Patients readmitted for NCS within 6 months of PCI were identified. Outcomes of interest were in-hospital death, myocardial infarction (MI), and bleeding defined by ICD-9 codes.ResultsAmong 221,379 patients who underwent PCI and survived to hospital discharge, 3.5% (n = 7696) were readmitted for NCS within 6 months post-PCI, and 41% of these hospitalizations were elective. Early NCS was complicated by MI in 4.7% of cases, and 21% of perioperative MI were fatal. Bleeding was recorded in 32.0% of patients. All-cause mortality occurred in 4.4% of patients (n = 339) readmitted for surgery. The risk of death or MI was greatest when NCS was performed within the first month after PCI.ConclusionsDespite clear guidelines to avoid surgery early after PCI, NCS was performed in 1 of every 29 patients with recent PCI, corresponding to as many as ~30,000 patients each year nationwide. Surgical mortality and perioperative MI was high in this setting. Strategies to minimize perioperative thrombotic and bleeding risks during readmission for NCS after PCI are necessary.Graphical Unlabelled Image
       
  • High prevalence of cholesterol-rich atherosclerotic lesions in ancient
           mummies: A near-infrared spectroscopy study
    • Abstract: Publication date: Available online 19 July 2019Source: American Heart JournalAuthor(s): Mohammad Madjid, Payam Safavi-Naeini, Robert Lodder Computed tomography has been used previously in mummies to detect arterial calcification, which is a marker of later-stage atherosclerosis. Here, using the novel approach of near-infrared spectroscopy, we detected cholesterol-rich atherosclerotic plaques in arterial samples from ancient mummies. In this proof-of-concept study, we are the first to noninvasively detect these earlier-stage lesions in mummies from different geographical areas, suggesting that atherosclerosis has been present in humans since ancient times.
       
  • Rationale and Design of a Nurse-led Intervention to extend the HIV
           
    • Abstract: Publication date: Available online 18 July 2019Source: American Heart JournalAuthor(s): Nwora Lance Okeke, Allison R. Webel, Hayden B. Bosworth, Angela Aifa, Gerald S. Bloomfield, Emily Choi, Sarah Gonzales, Sarah Hale, Corrilynn O. Hileman, Virginia Kidwell, Charles Muiruri, Megan Oakes, Julie Schexnayder, Valerie Smith, Rajesh Vedanthan, Chris T. Longenecker
       
  • The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte
           IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of
           atherosclerotic lesions: Trial design and rationale
    • Abstract: Publication date: Available online 13 July 2019Source: American Heart JournalAuthor(s): Laura Mauri, Gheorghe Doros, Sunil V. Rao, David J. Cohen, Steven Yakubov, John Lasala, S. Chiu Wong, James Zidar, Dean J. Kereiakes BackgroundCoronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting.Study Design and Objectives.Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. 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 non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs.ConclusionThe OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.
       
  • Premorbid levels of high-sensitivity cardiac troponin T and natriuretic
           peptide and prognosis after incident myocardial infarction
    • Abstract: Publication date: Available online 13 July 2019Source: American Heart JournalAuthor(s): Yejin Mok, Yingying Sang, Shoshana H. Ballew, Ron C. Hoogeveen, Christie M. Ballantyne, Wayne Rosamond, Josef Coresh, Elizabeth Selvin, Kunihiro Matushita BackgroundHigh-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) at the time of myocardial infarction (MI) are strong predictors of prognosis. However, whether their pre-morbid (before MI occurrence) levels are associated with prognosis after incident MI is unknown.MethodsIn 1054 participants from the Atherosclerosis Risk in Communities Study with incident MI, we evaluated premorbid levels of hs-cTnT and NT-proBNP measured on average 5.8 [IQI 3.0–11.5] years prior to incident MI, and their associations with subsequent composite and individual outcomes of all-cause mortality, cardiovascular mortality, recurrent MI, heart failure, and stroke.ResultsDuring a median follow-up of 3.0 years after MI, 801 participants developed the composite outcome. Both hs-cTnT and NT-proBNP were independently associated with the composite outcome after incident MI. Among individual outcomes, all-cause mortality, cardiovascular mortality, and heart failure showed significant associations with both cardiac markers. Overall, NT-proBNP demonstrated a more evident relationship than hs-cTnT. Indeed, the addition of premorbid NT-proBNP alone, but not hs-cTnT alone, to conventional predictors at incident MI significantly improved risk prediction of the composite outcome after incident MI (∆c-statistic 0.013 [95% CI 0.005–0.022] from 0.691 with conventional predictors).ConclusionsPremorbid levels of hs-cTnT and NT-proBNP assessed on average six years prior to incident MI were associated with adverse outcomes after incident MI. These results further highlight the importance of cardiac health at an earlier stage of life.
       
  • High-sensitivity C-reactive protein and the risk of chronic kidney disease
           
    • Abstract: Publication date: Available online 5 July 2019Source: American Heart JournalAuthor(s): Edouard L. Fu, Mikael Andersson Franko, Achim Obergfell, Friedo W. Dekker, Anders Gabrielsen, Tomas Jernberg, Juan Jesús Carrero BackgroundPersistent, low-grade inflammation likely participates in the pathophysiology of both atherosclerosis and kidney disease. While high-sensitivity C-reactive protein (hsCRP) predicts future cardiovascular risk in patients with chronic kidney disease (CKD), it is unknown whether hsCRP levels predict adverse renal outcomes in patients with cardiovascular disease.MethodsWe studied all myocardial infarction (MI) survivors undergoing hsCRP testing>30 days after their MI during routine healthcare in Stockholm, Sweden (2006–2011) with available information on estimated glomerular filtration rate (eGFR). HsCRP tests measured during hospitalization/emergency room visits, followed by antibiotics or indicative of acute illness, were excluded, together with patients with ongoing/recent cancer, chronic infections or immunosuppression. Inflammation was defined over a 3-month baseline window. Study outcomes were chronic kidney disease (CKD) progression (composite of doubling plasma creatinine, renal replacement therapy or renal death) and acute kidney injury (AKI, acute creatinine peaks according to KDIGO criteria). Multivariable Cox regression was used to adjust for age, sex, eGFR, hemoglobin, time since MI, comorbidities, undertaken procedures and medications.ResultsTotal 12,905 patients (62% men, mean age 73 years and 3 years since MI) were included, of whom 35% had an eGFR
       
  • Five-year clinical outcomes after percutaneous edge-to-edge mitral valve
           repair: Insights from the multicenter GRASP-IT registry
    • Abstract: Publication date: Available online 3 July 2019Source: American Heart JournalAuthor(s): Marianna Adamo, Carmelo Grasso, Davide Capodanno, Antonio Popolo Rubbio, Salvatore Scandura, Cristina Giannini, Francesca Fiorelli, Claudia Fiorina, Luca Branca, Nedy Brambilla, Francesco Bedogni, Anna Sonia Petronio, Salvatore Curello, Corrado Tamburino BackgroundLimited evidence is available on five-year clinical outcomes after percutaneous edge-to-edge mitral valve repair.MethodsThe GRASP-IT (Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly) is a multicenter registry including 304 consecutive patients undergoing Mitraclip between October 2008 and October 2013 at four Italian centers. Primary end-point (all-cause mortality) and secondary end-point (all-cause mortality or heart failure (HF) hospitalization) were evaluated up to 5-year and between 1- and 5-year.ResultsCumulative incidence of the primary and secondary end-points at 1, 2, 3, 4 and 5 years were 15.1%, 26.4%, 35.5%, 42.1% and 47.3%, and 29.1%, 41.7%, 49.8%, 56% and 62.3%, respectively. Landmark analysis between 1 and 5 years showed an incidence of primary and secondary end-point of 37.9% and 46.8% respectively. Five-year event rates were significantly higher in patients with functional ischaemic MR compared to other aetiologies. MR recurrence and left ventricular ejection fraction  5% was associated with an increased risk of 5-year mortality. Ischaemic etiology of MR, baseline serum-creatinine>1.5 mg/dl, COPD, and previous HF hospitalizations were independent predictors of 5-year secondary end-point.ConclusionsAt 5-year follow-up after Mitraclip nearly half of patients died and almost two-third died or were admitted for HF. MR recurrence, ischaemic etiology, high comorbidity burden (i.e. EuroSCORE II> 5%, COPD), and advanced cardiomyopathy (i.e. LVEF1.5 mg/dL) significantly increase the relative risk of 5-year clinical events.
       
  • The prevalence of atrial fibrillation on 48-hour ambulatory
           electrocardiography in African Americans compared to whites: The
           atherosclerosis risk in communities (ARIC) study
    • Abstract: Publication date: Available online 3 July 2019Source: American Heart JournalAuthor(s): Laura R Loehr, Elsayed Z Soliman, Anna K Poon, David Couper, Lin Yee Chen, Thomas H Mosley, Lynne E. Wagenknecht, Eric A Whitsel, Alvaro Alonso, Lisa Wruck, Gerardo Heiss BackgroundA lower prevalence of atrial fibrillation (AF), but paradoxically higher burden of cardiovascular disease risk factors, has been observed among African Americans compared to Whites in studies of AF identified by mostly 12-lead electrocardiograms (ECGs), and clinically.MethodsWe performed 48-hour ambulatory electrocardiography (aECG) in a biracial sample of 1193 participants in the Atherosclerosis Risk in Communities (ARIC) (mean age = 78 years, 62% African Americans, 64% female). Atrial fibrillation was identified from aECG, study visit ECGs, and discharge codes from cohort hospitalizations. We used covariate-adjusted logistic regression to estimate prevalence odds ratios for AF in African Americans versus Whites, with adjustment for sampling and non-response.ResultsAfrican Americans were more likely than Whites to have hypertension and diabetes, but less likely to have CHD. The prevalence of AF detected by aECG or ARIC study ECG (adjusted for age and CHD) was lower in African Americans than Whites (2.7% versus 5.0%). White men had a higher (although not significant) AF prevalence of 7.8% compared to the other race and gender groups at 2.3–2.8%. The adjusted OR for AF was 0.49 (0.24–0.99) comparing African-Americans to Whites. Findings were similar when AF was defined to include prior AF hospitalizations (OR = 0.42, 0.25–0.72). There were no significant differences by race for asymptomatic or paroxysmal AF.ConclusionsAtrial fibrillation was less prevalent in African American than White older adults, regardless of detection method. Although overall detection of new AF cases with aECG was low, future studies should consider longer term monitoring to characterize AF by race.
       
  • Targeted hypothermia versus targeted Normothermia after out-of-hospital
           cardiac arrest (TTM2). A randomized clinical trial – Rationale and
           design
    • Abstract: Publication date: Available online 26 June 2019Source: American Heart JournalAuthor(s): Josef Dankiewicz, Tobias Cronberg, Gisela Lilja, Janus Christian Jakobsen, Jan Bělohlávek, Clifton Callaway, Alain Cariou, Glenn Eastwood, David Erlinge, Jan Hovdenes, Michael Joannidis, Hans Kirkegaard, Michael Kuiper, Helena Levin, Matt P.G. Morgan, Alistair D Nichol, Per Nordberg, Mauro Oddo, Paolo Pelosi, Christian Rylander BackgroundLess than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted.MethodsThe TTM2-trial is an international, multicentre, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8 °C). Participants will be randomized within three hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded.The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4–6) at 180 days after arrest.DiscussionThe TTM2-trial will compare hypothermia to 33 °C with normothermia and early treatment of fever (≥37.8 °C) after out-of-hospital cardiac arrest.
       
  • Cardiovascular risk factor reduction by community health Workers in Rural
           India: A cluster randomized trial
    • Abstract: Publication date: Available online 19 June 2019Source: American Heart JournalAuthor(s): Rajnish Joshi, Twinkle Agarwal, Farah Fathima, T Usha, Tinku Thomas, Dominic Misquith, SP Kalantri, N Chidambaram, Tony Raj, Alben Singamani, Shailendra Hegde, Denis Xavier, PJ Devereaux, Prem Pais, Rajeev Gupta, Salim Yusuf BackgroundThere is a need to identify and test low cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy.ObjectiveCommunity health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India.MethodsWe performed an open-label cluster-randomized trial in 28 villages in 3 states of India with the household as a unit of randomization. Households with individuals at intermediate to high CVD risk were randomized to intervention and control groups. In the intervention group, trained CHWs delivered risk-reduction advice and monitored risk factors during 6 household visits over 12 months. Households in the non-intervention group received usual care. Primary outcomes were a reduction in systolic BP (SBP) and adherence to prescribed BP lowering drugs.ResultsWe randomized 2312 households (3261 participants at intermediate or high risk) to intervention (1172 households) and control (1140 households). At baseline prevalence of tobacco use (48.5%) and hypertension (34.7%) were high. At 12 months, there was significant decline in SBP (mmHg) from baseline in both groups- controls 130.3 ± 21 to 128.3 ± 15; intervention 130.3 ± 21 to 127.6 ± 15 (P 
       
  • Simulation of impact on cardiovascular events due to lipid-lowering
           therapy intensification in a population with atherosclerotic
           cardiovascular disease
    • Abstract: Publication date: Available online 12 June 2019Source: American Heart JournalAuthor(s): Christopher P. Cannon, Irfan Khan, Alexa C. Klimchak, Robert J. Sanchez, William J. Sasiela, Joseph M. Massaro, Ralph B. D'Agostino, Matthew R. ReynoldsBackgroundIn patients with atherosclerotic cardiovascular disease (ASCVD), guidelines recommend statins as first-line lipid-lowering therapy (LLT) with addition of non-statin agents in those with persistently elevated low-density lipoprotein cholesterol (LDL-C) levels.MethodsTo estimate the cardiovascular (CV) risk reduction implications of treatment intensification, we utilized a previously reported simulation model with enhancements. An ASCVD cohort was developed from a US claims database. A Cox model was utilized to estimate baseline risk of CV events: myocardial infarction, ischemic stroke, unstable angina hospitalization, elective coronary revascularization, or cardiovascular death. Patients were sampled with replacement (bootstrapping) and entered the simulation model which applied stepwise LLT intensification logic, with a goal of achieving LDL-C less than 70 mg/dL at each step. CV risk reduction assumptions were based on published data. Two treatment intensification scenarios were investigated: ideal and real-world (which accounted for statin intolerance, non-adherence, and payer restrictions).ResultsIn a cohort of 1000 ASCVD patients, approximately 813 (809–818) would require treatment intensification with LLT under an ideal treatment intensification scenario. Before treatment intensification, 183 (179–187) events would be expected to occur over 5 years. With treatment intensification, 40 (34–45) of these events could be avoided. In a real-world scenario, about 818 (813–823) patients require treatment intensification with LLT, resulting in 29 (24–34) events avoided over 5 years.ConclusionsIntensification of LLT in an ASCVD population translates into a substantial number of CV events avoided. This simulation-based model could assist in assessing the potential benefits of various types of population-level LLT interventions.
       
  • Clinical effects of cyclosporine in acute anterior myocardial infarction
           complicated by heart failure: A subgroup analysis of the CIRCUS trial
    • Abstract: Publication date: Available online 30 May 2019Source: American Heart JournalAuthor(s): Marc J Claeys, Patrick Coussement, Philippe Dubois, D. Garcia-Dorado, N. Mewton, C Amaz, M. Ovize The present exploratory substudy of the CIRCUS trial demonstrates that the administration of Cyclosporine prior to PCI did not reduce infarct size and had no clinical effect in acute anterior myocardial infarction complicated by heart failure.
       
  • Correction to “Sex differences in long-term outcomes of patients across
           the spectrum of coronary artery disease”, [American Heart Journal
           (December 2018) 51-60]
    • Abstract: Publication date: Available online 29 May 2019Source: American Heart JournalAuthor(s):
       
  • Design and rationale for the stimulation of the left ventricular
           endocardium for cardiac resynchronization therapy in non-responders and
           previously untreatable patients (SOLVE-CRT) trial
    • Abstract: Publication date: Available online 9 April 2019Source: American Heart JournalAuthor(s): Jagmeet P. Singh, William T. Abraham, Angelo Auricchio, Peter Paul Delnoy, Michael Gold, Vivek Y. Reddy, Prashanthan Sanders, JoAnn Lindenfeld, Christopher A Rinaldi BackgroundCardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems. A new wireless endocardial left ventricular (LV) pacing system allows CRT without such limitations and has shown promise in open-label studies. The purpose of this study is to evaluate its use in a patient population with poor therapeutic alternatives.MethodsThe SOLVE CRT study is an international, multi-center, randomized, double-blind, sham-controlled trial of patients with Class I and IIa indications for CRT who have either failed to respond to or have been unable to receive conventional CRT. Enrollment will comprise 350 patients implanted with the wireless CRT system randomized 1:1 to therapy on (Treatment) or therapy off (Control) for the six-month period over which trial primary endpoints will be evaluated. The primary safety endpoint will measure the proportion of patients free from system- and procedure-related complications. Primary efficacy endpoints will assess absolute change in LV end-systolic volume LVESV, proportion of patients reducing LVESV by ≥15% and clinical composite score for Treatment versus Control patients. Primary endpoints will be evaluated on an intention-to-treat basis, though per-protocol and as-treated analysis will also be performed.ConclusionSOLVE-CRT will quantify the safety and effectiveness of wireless CRT in non-responders to conventional CRT and indicated patients who have been unable to receive CRT via the usual transvenous approach.
       
  • Temporal evolution of myeloperoxidase and galectin 3 during 1 year after
           acute coronary syndrome admission
    • Abstract: Publication date: Available online 6 April 2019Source: American Heart JournalAuthor(s): Maxime M. Vroegindewey, Victor J. van den Berg, Elke Bouwens, K. Martijn Akkerhuis, Rohit M. Oemrawsingh, Folkert W Asselbergs, Timo Lenderink, Pim van der Harst, Eelco Ronner, Victor A.W.M. Umans, Isabella Kardys, Eric Boersma Prior studies reported that Myeloperoxidase and Galectin-3, which are biomarkers of coronary plaque vulnerability, are elevated in acute coronary syndrome (ACS) patients. We studied the temporal evolution of these biomarkers early after ACS admission and prior to a recurrent ACS event during 1 year follow-up.
       
 
 
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