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Publisher: Elsevier   (Total: 3048 journals)

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Showing 1 - 200 of 3048 Journals sorted alphabetically
A Practical Logic of Cognitive Systems     Full-text available via subscription   (Followers: 7)
AASRI Procedia     Open Access   (Followers: 15)
Academic Pediatrics     Hybrid Journal   (Followers: 25, SJR: 1.402, h-index: 51)
Academic Radiology     Hybrid Journal   (Followers: 22, SJR: 1.008, h-index: 75)
Accident Analysis & Prevention     Partially Free   (Followers: 86, SJR: 1.109, h-index: 94)
Accounting Forum     Hybrid Journal   (Followers: 25, SJR: 0.612, h-index: 27)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 30, 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: 363, 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: 228, 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: 10, 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: 1)
Acta Poética     Open Access   (Followers: 4)
Acta Psychologica     Hybrid Journal   (Followers: 24, 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)
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Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 5, SJR: 0.141, h-index: 3)
Actualites Pharmaceutiques Hospitalieres     Full-text available via subscription   (Followers: 4, SJR: 0.112, h-index: 2)
Acupuncture and Related Therapies     Hybrid Journal   (Followers: 4)
Acute Pain     Full-text available via subscription   (Followers: 13)
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: 6)
Additive Manufacturing     Hybrid Journal   (Followers: 7, SJR: 1.039, h-index: 5)
Additives for Polymers     Full-text available via subscription   (Followers: 21)
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: 17, 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: 26, 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)
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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 Cell Aging and Gerontology     Full-text available via subscription   (Followers: 4)
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: 27, 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: 9, SJR: 1.268, h-index: 45)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 29, 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 Dermatology     Full-text available via subscription   (Followers: 12)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 11)
Advances in Digestive Medicine     Open Access   (Followers: 6)
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: 44, SJR: 3.25, h-index: 43)
Advances in Engineering Software     Hybrid Journal   (Followers: 26, 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: 42, 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: 50, SJR: 0.674, h-index: 38)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 16)
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: 12)
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: 22, SJR: 0.906, h-index: 24)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 9, 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: 36, 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: 6)
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: 8, 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 Organ Biology     Full-text available via subscription   (Followers: 2)
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: 8, 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: 17)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 20, SJR: 1.5, h-index: 62)
Advances in Psychology     Full-text available via subscription   (Followers: 62)
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 Biology and Medicine     Full-text available via subscription   (Followers: 5)
Advances in Space Research     Full-text available via subscription   (Followers: 361, 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: 44, 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: 329, 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: 413, SJR: 1.385, h-index: 72)
Agri Gene     Hybrid Journal  
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 16, SJR: 2.18, h-index: 116)
Agricultural Systems     Hybrid Journal   (Followers: 30, SJR: 1.275, h-index: 74)
Agricultural Water Management     Hybrid Journal   (Followers: 40, 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: 55, 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: 11, SJR: 0.922, h-index: 66)
Alcoholism and Drug Addiction     Open Access   (Followers: 8)
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   (Followers: 1)
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)
Alpha Omegan     Full-text available via subscription   (SJR: 0.121, h-index: 9)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 9, SJR: 0.158, h-index: 9)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 46, SJR: 4.289, h-index: 64)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 4)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 4)
Ambulatory Pediatrics     Hybrid Journal   (Followers: 5)
American Heart J.     Hybrid Journal   (Followers: 48, SJR: 3.157, h-index: 153)
American J. of Cardiology     Hybrid Journal   (Followers: 47, SJR: 2.063, h-index: 186)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 40, SJR: 0.574, h-index: 65)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 9, SJR: 1.091, h-index: 45)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 14, SJR: 1.653, h-index: 93)
American J. of Human Genetics     Hybrid Journal   (Followers: 32, SJR: 8.769, h-index: 256)
American J. of Infection Control     Hybrid Journal   (Followers: 26, SJR: 1.259, h-index: 81)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 32, 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: 200, SJR: 2.255, h-index: 171)
American J. of Ophthalmology     Hybrid Journal   (Followers: 59, SJR: 2.803, h-index: 148)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 6)
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: 25, 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: 24, SJR: 2.764, h-index: 154)
American J. of Surgery     Hybrid Journal   (Followers: 35, 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: 58, SJR: 0.124, h-index: 9)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 12)
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: 4, SJR: 2.577, h-index: 7)
Analytica Chimica Acta     Hybrid Journal   (Followers: 37, SJR: 1.548, h-index: 152)
Analytical Biochemistry     Hybrid Journal   (Followers: 166, 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: 12)
Anesthésie & Réanimation     Full-text available via subscription   (Followers: 1)
Anesthesiology Clinics     Full-text available via subscription   (Followers: 23, 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: 172, SJR: 1.907, h-index: 126)

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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  [3048 journals]
  • Valve hemodynamic deterioration and cardiovascular outcomes in TAVR: A
           report from the STS/ACC TVT Registry
    • Authors: Sreekanth Vemulapalli; David R. Holmes; David Dai; Roland Matsouaka; Michael J. Mack; Fred L. Grover; Raj R. Makkar; Vinod H. Thourani; Pamela S. Douglas
      Pages: 1 - 13
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Sreekanth Vemulapalli, David R. Holmes, David Dai, Roland Matsouaka, Michael J. Mack, Fred L. Grover, Raj R. Makkar, Vinod H. Thourani, Pamela S. Douglas
      Background Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes. Methods and Results Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). VHD was defined as an increase in mean aortic valve gradient ≥10 mm Hg. Eighteen-month cardiovascular outcomes were determined via linkage with Centers for Medicare & Medicaid Services claims. Backwards selection logistic regression was performed to determine predictors of VHD. Among 10,099 TAVRs with paired echocardiograms, the median age was 84 years and 48.7% were female, with Society of Thoracic Surgeons score distributions of <8% (61.7%), 8%-15% (28.8%), and >15% (9.5%). The incidence of VHD was 2.1% in the early cohort and 2.5% in the late cohort. There was no significant difference between those with and without VHD in either cohort in the combined end point of death/stroke/aortic valve reintervention or heart failure hospitalization or myocardial infarction. Independent predictors of VHD included chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, severe patient-prosthesis mismatch, increasing body mass index, and increasing baseline aortic valve gradient. Conclusions The incidence of VHD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months. Patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.09.005
      Issue No: Vol. 195 (2017)
       
  • Drug-induced cardiac abnormalities in premature infants and neonates
    • Authors: Luana Pesco-Koplowitz; Gary Gintant; Robert Ward; Dominique Heon; Muriel Saulnier; Jeff Heilbraun
      Pages: 14 - 38
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Luana Pesco-Koplowitz, Gary Gintant, Robert Ward, Dominique Heon, Muriel Saulnier, Jeff Heilbraun
      The Cardiac Safety Research Consortium (CSRC) is a transparent, public-private partnership that was established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University. Our continuing goal is to advance paradigms for more efficient regulatory science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where such safety questions add burden to innovative research and development. This White Paper provides a summary of discussions by a cardiovascular committee cosponsored by the CSRC and the US Food and Drug Administration (FDA) that initially met in December 2014, and periodically convened at FDA's White Oak headquarters from March 2015 to September 2016. The committee focused on the lack of information concerning the cardiac effects of medications in the premature infant and neonate population compared with that of the older pediatric and adult populations. Key objectives of this paper are as follows: Provide an overview of human developmental cardiac electrophysiology, as well as the electrophysiology of premature infants and neonates; summarize all published juvenile animal models relevant to drug-induced cardiac toxicity; provide a consolidated source for all reported drug-induced cardiac toxicities by therapeutic area as a resource for neonatologists; present drugs that have a known cardiac effect in an adult population, but no reported toxicity in the premature infant and neonate populations; and summarize what is not currently known about drug-induced cardiac toxicity in premature infants and neonates, and what could be done to address this lack of knowledge. This paper presents the views of the authors and should not be construed to represent the views or policies of the FDA or Health Canada.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.07.014
      Issue No: Vol. 195 (2017)
       
  • Global geographical variation in patient characteristics in percutaneous
           coronary intervention clinical trials: A systematic review and
           meta-analysis
    • Authors: Eden Liu; Leon Hsueh; Hajwa Kim; Mladen I. Vidovich
      Pages: 39 - 49
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Eden Liu, Leon Hsueh, Hajwa Kim, Mladen I. Vidovich
      Background We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. Methods We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors—hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. Results In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P <.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P =.0035) and HL (63.72%, P <.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P <.0001) and smoking (38.41%, P =.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P <.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (β<0.02) statistically significant temporal trends over time, except for sex. Conclusions There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.09.003
      Issue No: Vol. 195 (2017)
       
  • Association of insurance type with receipt of oral anticoagulation in
           insured patients with atrial fibrillation: A report from the American
           College of Cardiology NCDR PINNACLE registry
    • Authors: Celina M. Yong; Yuyin Liu; Patricia Apruzzese; Gheorghe Doros; Christopher P. Cannon; Thomas M. Maddox; Anil Gehi; Jonathan C. Hsu; Steven A. Lubitz; Salim Virani; Mintu P. Turakhia
      Pages: 50 - 59
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Celina M. Yong, Yuyin Liu, Patricia Apruzzese, Gheorghe Doros, Christopher P. Cannon, Thomas M. Maddox, Anil Gehi, Jonathan C. Hsu, Steven A. Lubitz, Salim Virani, Mintu P. Turakhia
      It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs). Methods We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). Results In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P <.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P <.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription. Conclusions In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.010
      Issue No: Vol. 195 (2017)
       
  • Mineralocorticoid receptor antagonists in patients with acute myocardial
           
    • Authors: Matthias Bossard; Yasser Binbraik; Farzin Beygui; Bertram Pitt; Faiez Zannad; Gilles Montalescot; Sanjit S. Jolly
      Pages: 60 - 69
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Matthias Bossard, Yasser Binbraik, Farzin Beygui, Bertram Pitt, Faiez Zannad, Gilles Montalescot, Sanjit S. Jolly
      Background Although mineralocorticoid antagonists (MRAs) reduce mortality in patients with heart failure complicating myocardial infarction (MI), it is unclear if they could be beneficial to all patients with MI. To evaluate the utility of MRAs in MI patients, we performed a systematic review and meta-analysis. Methods MEDLINE, EMBASE, and Cochrane CENTRAL were searched from 1965 to June 2016. Conference abstracts were searched from 2000 to June 2016. Randomized trials evaluating the effect of MRA after MIs were included. Two reviewers independently extracted data and assessed study quality. Data were combined using fixed-/random-effects models. Results Eleven randomized clinical trials (N = 11,258) were included; 1 trial (N = 6,642) included patients with apparent heart failure (Killip class III-IV). Administration of MRA versus placebo or standard therapy (no-MRA) after MI reduced overall and cardiovascular mortality (odds ratio [OR] 0.82, 95% CI 0.73-0.93, P = .002, and OR 0.82, 95% CI 0.71-0.93, P = .003, respectively; I 2 for both = 0%). In the subgroup of trials with patients with heart failure, the mortality was 14.4% in MRA group versus 16.7% in no-MRA group (OR 0.84, 95% CI 0.73-0.96), and among those without heart failure, it was 2.5% with MRA versus 3.5% without MRA (OR 0.72, 95% CI 0.51-1.02, P for interaction = .43). Patients receiving MRA had fewer new or worsening heart failure events (OR 0.74, 95% CI 0.66-0.84, P < .0001; I 2 = 14%). Nevertheless, MRA therapy increased risk for hyperkalemia (≥5.5 mmol/L) (OR 2.52, 95% CI 1.36-4.65, P = .003; I 2 = 63%). Conclusions Administration of MRA may reduce mortality after acute MI. However, this is largely based on post-MI patients with heart failure. Further data are needed in MI patients without heart failure.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.09.010
      Issue No: Vol. 195 (2017)
       
  • Effect of high-dose oral multivitamins and minerals in participants not
           treated with statins in the randomized Trial to Assess Chelation Therapy
           (TACT)
    • Authors: Omar M. Issa; Rhonda Roberts; Daniel B. Mark; Robin Boineau; Christine Goertz; Yves Rosenberg; Eldrin F. Lewis; Erminia Guarneri; Jeanne Drisko; Allan Magaziner; Kerry L. Lee; Gervasio A. Lamas
      Pages: 70 - 77
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Omar M. Issa, Rhonda Roberts, Daniel B. Mark, Robin Boineau, Christine Goertz, Yves Rosenberg, Eldrin F. Lewis, Erminia Guarneri, Jeanne Drisko, Allan Magaziner, Kerry L. Lee, Gervasio A. Lamas
      Importance In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. Objective To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. Design TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post–myocardial infarction (MI) patients 50 years or older. Participants There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. Setting Patients were enrolled at 134 sites around the United States and Canada. Intervention Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). Main outcome The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. Results The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P =.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P =.002). Multiple end point analyses were consistent with these results. Conclusion and relevance High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.09.002
      Issue No: Vol. 195 (2017)
       
  • Efficacy and safety of potent platelet P2Y12 receptor inhibitors in
           elderly versus nonelderly patients with acute coronary syndrome: A
           systematic review and meta-analysis
    • Authors: Giuseppe Tarantini; Daisuke Ueshima; Gianpiero D'Amico; Giulia Masiero; Giuseppe Musumeci; Gregg W. Stone; Sorin J. Brener
      Pages: 78 - 85
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Giuseppe Tarantini, Daisuke Ueshima, Gianpiero D'Amico, Giulia Masiero, Giuseppe Musumeci, Gregg W. Stone, Sorin J. Brener
      Background The use of the potent oral P2Y12 inhibitors prasugrel and ticagrelor in patients with acute coronary syndromes (ACS) has a favorable net clinical effect compared with clopidogrel and is recommended as first-line therapy. However, the impact of these agents on ischemic and bleeding events in elderly ACS patients is not well defined. Methods We performed a systematic review of articles comparing potent P2Y12 inhibitors to clopidogrel in elderly and nonelderly patients (defined according to each study) with ACS in terms of efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (major bleeding) end points. Results A total of 7,860 elderly and 37,857 nonelderly patients from 7 studies (5 randomized control trials and 2 observational studies) were included. Potent P2Y12 inhibitors significantly reduced efficacy end point in nonelderly patients (relative risk [RR] 0.85, 95% CI 0.79-0.93) and less so in elderly patients (RR 0.95, 95% CI 0.86-1.05). No significant differences were found between potent P2Y12 inhibitors and clopidogrel in terms of safety end point in both elderly (RR 1.19, 95% CI 0.95-1.49) and nonelderly patients (RR 1.16, 95% CI 0.95-1.41). There were no significant interactions between age and treatment effect in both analyses (efficacy P int =.16; safety P int =.83). Conclusions The effect of more potent P2Y12 inhibitors compared with clopidogrel on efficacy and safety end points is consistent in elderly and younger patients. These data imply that potent P2Y12 inhibitors should not be withheld from eligible patients solely because of advanced age.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.09.012
      Issue No: Vol. 195 (2017)
       
  • Predictors of perioperative major bleeding in patients who interrupt
           warfarin for an elective surgery or procedure: Analysis of the BRIDGE
           trial
    • Authors: Nathan P. Clark; James D. Douketis; Vic Hasselblad; Sam Schulman; Andrei L. Kindzelski; Thomas L. Ortel
      Pages: 108 - 114
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Nathan P. Clark, James D. Douketis, Vic Hasselblad, Sam Schulman, Andrei L. Kindzelski, Thomas L. Ortel
      Background The use of low–molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. Methods BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors. Results We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high–bleeding risk procedures (vs low–bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9). Conclusions In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high–bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.09.015
      Issue No: Vol. 195 (2017)
       
  • A multinational clinical approach to assessing the effectiveness of
           catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE
           clinical study designs
    • Authors: Laura Mauri; Kazuomi Kario; Jan Basile; Joost Daemen; Justin Davies; Ajay J. Kirtane; Felix Mahfoud; Roland E. Schmieder; Michael Weber; Shinsuke Nanto; Michel Azizi
      Pages: 115 - 129
      Abstract: Publication date: January 2018
      Source:American Heart Journal, Volume 195
      Author(s): Laura Mauri, Kazuomi Kario, Jan Basile, Joost Daemen, Justin Davies, Ajay J. Kirtane, Felix Mahfoud, Roland E. Schmieder, Michael Weber, Shinsuke Nanto, Michel Azizi
      Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure–lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts—SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.09.006
      Issue No: Vol. 195 (2017)
       
  • Late outcome of percutaneous mitral commissurotomy: Randomized comparison
           of Inoue versus double-balloon technique
    • Authors: Sahmin Lee; Duk-Hyun Kang; Dae-Hee Kim; Jong-Min Song; Jae-Kwan Song; Seong-Wook Park; Seung-Jung Park
      Pages: 1 - 8
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Sahmin Lee, Duk-Hyun Kang, Dae-Hee Kim, Jong-Min Song, Jae-Kwan Song, Seong-Wook Park, Seung-Jung Park
      Background Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25 years in a randomized trial. Methods Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double-balloon technique (n = 150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3. Results During median follow-up of 20.7 years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event-free survival rates at 24 years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65–1.20; P = .423). On multivariate analysis, absence of post-PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28–2.63; P = .001) and immediate post-PMC mitral valve area (MVA) <1.8 cm2 (HR, 1.53; 95% CI, 1.04–2.25; P = .031) were independently correlated with clinical events after successful PMC. Conclusions The Inoue and double-balloon methods showed similar good clinical outcomes up to 25 years, and the achievement of effective commissurotomy to develop post-PMC commissural MR or immediate post-PMC MVA ≥1.8 cm2 is important in optimizing the late results of PMC.

      PubDate: 2017-09-22T12:39:36Z
      DOI: 10.1016/j.ahj.2017.04.004
      Issue No: Vol. 194 (2017)
       
  • A unique linkage of administrative and clinical registry databases to
           
    • Authors: Justin Godown; Cary Thurm; Debra A. Dodd; Jonathan H. Soslow; Brian Feingold; Andrew H. Smith; Bret A. Mettler; Bryn Thompson; Matt Hall
      Pages: 9 - 15
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Justin Godown, Cary Thurm, Debra A. Dodd, Jonathan H. Soslow, Brian Feingold, Andrew H. Smith, Bret A. Mettler, Bryn Thompson, Matt Hall
      Background Large clinical, research, and administrative databases are increasingly utilized to facilitate pediatric heart transplant (HTx) research. Linking databases has proven to be a robust strategy across multiple disciplines to expand the possible analyses that can be performed while leveraging the strengths of each dataset. We describe a unique linkage of the Scientific Registry of Transplant Recipients (SRTR) database and the Pediatric Health Information System (PHIS) administrative database to provide a platform to assess resource utilization in pediatric HTx. Methods All pediatric patients (1999-2016) who underwent HTx at a hospital enrolled in the PHIS database were identified. A linkage was performed between the SRTR and PHIS databases in a stepwise approach using indirect identifiers. To determine the feasibility of using these linked data to assess resource utilization, total and post-HTx hospital costs were assessed. Results A total of 3188 unique transplants were identified as being present in both databases and amenable to linkage. Linkage of SRTR and PHIS data was successful in 3057 (95.9%) patients, of whom 2896 (90.8%) had complete cost data. Median total and post-HTx hospital costs were $518,906 (IQR $324,199-$889,738), and $334,490 (IQR $235,506-$498,803) respectively with significant differences based on patient demographics and clinical characteristics at HTx. Conclusions Linkage of the SRTR and PHIS databases is feasible and provides an invaluable tool to assess resource utilization. Our analysis provides contemporary cost data for pediatric HTx from the largest US sample reported to date. It also provides a platform for expanded analyses in the pediatric HTx population.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.014
      Issue No: Vol. 194 (2017)
       
  • Contemporary risk model for inhospital 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
      Pages: 16 - 24
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      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 inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. Methods An inhospital 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 12 g/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 inhospital 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: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.004
      Issue No: Vol. 194 (2017)
       
  • Contemporary rates and correlates of statin use and adherence in
           nondiabetic adults with cardiovascular risk factors: The KP CHAMP study
    • Authors: Alan S. Go; Dongjie Fan; Sue Hee Sung; Alda I. Inveiss; Victoria Romo-LeTourneau; Usha G. Mallya; Susan Boklage; Joan C. Lo
      Pages: 25 - 38
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Alan S. Go, Dongjie Fan, Sue Hee Sung, Alda I. Inveiss, Victoria Romo-LeTourneau, Usha G. Mallya, Susan Boklage, Joan C. Lo
      Background Statin therapy is highly efficacious in the prevention of fatal and nonfatal atherosclerotic events in persons at increased cardiovascular risk. However, its long-term effectiveness in practice depends on a high level of medication adherence by patients. Methods We identified nondiabetic adults with cardiovascular risk factors between 2008 and 2010 within a large integrated health care delivery system in Northern California. Through 2013, we examined the use and adherence of newly initiated statin therapy based on data from dispensed prescriptions from outpatient pharmacy databases. Results Among 209,704 eligible adults, 68,085 (32.5%) initiated statin therapy during the follow-up period, with 90.4% receiving low-potency statins. At 12 and 24 months after initiating statins, 84.3% and 80.2%, respectively, were actively receiving statin therapy, but only 42% and 30%, respectively, had no gaps in treatment during those time periods. There was also minimal switching between statins or use of other lipid-lowering therapies for augmentation during follow-up. Age≥50 years, Asian/Pacific Islander race, Hispanic ethnicity, prior myocardial infarction, prior ischemic stroke, hypertension, and baseline low-density lipoprotein cholesterol>100 mg/dL were associated with higher adjusted odds, whereas female gender, black race, current smoking, dementia were associated with lower adjusted odds, of active statin treatment at 12 months after initiation. Conclusions There remain opportunities for improving prevention in patients at risk for cardiovascular events. Our study identified certain patient subgroups that may benefit from interventions to enhance medication adherence, particularly by minimizing treatment gaps and discontinuation of statin therapy within the first year of treatment.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.013
      Issue No: Vol. 194 (2017)
       
  • 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
      Pages: 39 - 48
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      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 1 year of follow-up is unknown. Methods and results Six hundred thirty-nine 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 36 months 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 to 12 months. Although there were small declines in health status after 12 months, the initial benefits of TAVR were largely sustained through 3 years 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 3 years 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: 2017-10-04T20:47:13Z
      DOI: 10.1016/j.ahj.2017.08.006
      Issue No: Vol. 194 (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
      Pages: 61 - 72
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      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 2,354 consecutive PCI cases (1,243 acute cases, 52.8%) from 3 Japanese cardiovascular centers from 2011 to 2015. In-hospital complications were predefined under consensus definitions (eg, 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 US $14,840 (interquartile range [IQR] 11,370-20,070) and US $11,030 (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 1.66, 95% CIs 1.13-2.43; elective: odds ratio 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 US $9,840 for each AKI event, and the total cost increase reached US $2,588,035. Conclusions Procedure-related complications, particularly postprocedural 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: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.008
      Issue No: Vol. 194 (2017)
       
  • 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
      Pages: 73 - 82
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      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
      Background 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 (>65 years 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 30 days were analyzed. 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: 2017-10-11T21:06:20Z
      DOI: 10.1016/j.ahj.2017.08.009
      Issue No: Vol. 194 (2017)
       
  • “Bringing on the light” in a complex clinical scenario: Optical
           coherence tomography–guided discontinuation of antiplatelet therapy in
           cancer patients with coronary artery disease (PROTECT-OCT registry)
    • Authors: Cezar A. Iliescu; Mehmet Cilingiroglu; Dana E. Giza; Oscar Rosales; Jake Lebeau; Israel Guerrero-Mantilla; Juan Lopez-Mattei; Juhee Song; Guillherme Silva; Pranav Loyalka; Andre R.M. Paixao; Wamique Yusuf; Emerson Perin; Vernon H. Anderson; Konstantinos Marmagkiolis
      Pages: 83 - 91
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Cezar A. Iliescu, Mehmet Cilingiroglu, Dana E. Giza, Oscar Rosales, Jake Lebeau, Israel Guerrero-Mantilla, Juan Lopez-Mattei, Juhee Song, Guillherme Silva, Pranav Loyalka, Andre R.M. Paixao, Wamique Yusuf, Emerson Perin, Vernon H. Anderson, Konstantinos Marmagkiolis
      Background Cancer patients with recently placed drug-eluting stents (DESs) often require premature dual antiplatelet therapy (DAPT) discontinuation for cancer-related procedures. Optical coherence tomography (OCT) can identify risk factors for stent thrombosis such as stent malapposition, incomplete strut coverage and in-stent restenosis and may help guide discontinuation of DAPT. Methods We conducted a single-center prospective study in cancer patients with recently placed (1-12 months) DES who required premature DAPT discontinuation. Patients were evaluated with diagnostic coronary angiogram and OCT. Individuals with appropriate stent strut coverage, expansion, apposition, and absence of in-stent restenosis or intraluminal masses were considered low risk and transiently discontinued DAPT to allow optimal cancer therapy. Patients who did not meet all these criteria were considered high risk and underwent further endovascular treatment when appropriate and bridging with low-molecular weight heparin. The incidence of adverse cardiovascular events was assessed after the procedure and at 12 months. Results A total of 40 patients were included. Twenty-seven patients (68%) were considered low risk by OCT criteria and DAPT was transiently discontinued. Thirteen patients (32%) were considered high risk with one or more OCT findings: uncovered stent struts (4 patients, 10%); stent underexpansion (3 patients, 8%); malapposition (8 patients, 20%); in-stent restenosis (2 patients, 5%). The high-risk patients with uncovered stent struts and malapposition underwent additional stent dilatation. There were no cardiovascular events in the low-risk group. One myocardial infarction occurred in the high-risk group. Fourteen non-cardiac deaths were registered before 12 months due to cancer progression or cancer therapy. Conclusion OCT imaging allows identification of low-risk cancer patients with DES placed who may safely discontinue DAPT and proceed with cancer-related surgery or procedures.

      PubDate: 2017-10-11T21:06:20Z
      DOI: 10.1016/j.ahj.2017.08.015
      Issue No: Vol. 194 (2017)
       
  • Outcomes of cardiac pacing in adult patients after a Fontan operation
    • Authors: Alexander C. Egbe; Geoffery D. Huntley; Heidi M. Connolly; Naser M. Ammash; Abhishek J. Deshmukh; Arooj R. Khan; Sameh M. Said; Emmanuel Akintoye; Carole A. Warnes; Suraj Kapa
      Pages: 92 - 98
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Alexander C. Egbe, Geoffery D. Huntley, Heidi M. Connolly, Naser M. Ammash, Abhishek J. Deshmukh, Arooj R. Khan, Sameh M. Said, Emmanuel Akintoye, Carole A. Warnes, Suraj Kapa
      Background Cardiac pacing can be challenging after a Fontan operation, and limited data exist regarding pacing in adult Fontan patients. The objectives of our study were to determine risk factors for pacing and occurrence of device-related complications (DRCs) and pacemaker reinterventions. Methods We performed a retrospective review of Fontan patients from 1994 through 2014. We defined DRCs as lead failure, lead recall, cardiac perforation, lead thrombus/vegetation, or device-related infection, and cardiovascular adverse events (CAEs) as venous thrombosis, stroke, death, or heart transplant. Pacemaker reintervention was defined as lead failure or recall. Results Of 439 patients, 166 (38%) had pacemakers implanted (79 during childhood; 87, adulthood); 114 patients (69%) received epicardial leads initially, and 52 (31%), endocardial leads. Pacing was initially atrial in 52 patients (31%); ventricular, 30 (18%); or dual chamber, 84 (51%). There were 37 reinterventions (1.9% per year) and 48 DRCs (2.4% per year). Pacemaker implantation during childhood was a risk factor for DRCs (hazard ratio, 2.01 [CI, 1.22-5.63]; P = .03). There were 70 CAEs (venous thrombosis, 5; stroke, 11; transplant, 8; and death, 46), yielding a rate of 3.5% per year. DRCs, CAEs, and reintervention rates were comparable for patients with epicardial or endocardial leads. Conclusions More than one-third of adult Fontan patients referred to Mayo Clinic had pacemaker implantation. Epicardial leads were associated with high rate of pacemaker reinterventions but similar DRC rates in comparison to endocardial leads.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.019
      Issue No: Vol. 194 (2017)
       
  • Edoxaban for the management of elderly Japanese patients with atrial
           fibrillation ineligible for standard oral anticoagulant therapies:
           Rationale and design of the ELDERCARE-AF study
    • Authors: Ken Okumura; Gregory Y.H. Lip; Masaharu Akao; Kimihiko Tanizawa; Masayuki Fukuzawa; Kenji Abe; Masahiro Akishita; Takeshi Yamashita
      Pages: 99 - 106
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Ken Okumura, Gregory Y.H. Lip, Masaharu Akao, Kimihiko Tanizawa, Masayuki Fukuzawa, Kenji Abe, Masahiro Akishita, Takeshi Yamashita
      Edoxaban—a non–vitamin K antagonist oral anticoagulant (NOAC)— 60-mg and 30-mg once-daily dose regimens are noninferior versus well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF patients, especially those considered ineligible for available oral anticoagulants. The Edoxaban Low-Dose for EldeR CARE AF patients (ELDERCARE-AF) study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that will compare the safety and efficacy of once-daily edoxaban 15 mg versus placebo in Japanese patients with NVAF ≥80 years of age who are considered ineligible for standard oral anticoagulant therapy. A total of 800 patients (400 in each treatment group) are planned for randomization (1:1) to either edoxaban or placebo using a stratified randomization method with CHADS2 index score (2 points, ≥3 points) as a factor. The primary efficacy end point is the time to first onset of stroke or SEE. The net clinical outcome is the composite of stroke, SEE, major bleeding, and all-cause mortality. The primary safety end point is the incidence of major bleeding. The treatment period will continue until 65 patients with the primary efficacy events (ie, stroke or SEE) have been observed (2- to 2.5-year expected mean treatment period). The results of ELDERCARE-AF may provide clarity as to the efficacy and safety of edoxaban for the prevention of stroke or SEE in this high-risk population.

      PubDate: 2017-10-18T13:26:16Z
      DOI: 10.1016/j.ahj.2017.08.017
      Issue No: Vol. 194 (2017)
       
  • Enabling social listening for cardiac safety monitoring: Proceedings from
           a drug information association–cardiac safety research consortium
           cosponsored think tank
    • Authors: Harry A. Seifert; Raleigh E. Malik; Mondira Bhattacharya; Kevin R. Campbell; Sally Okun; Carrie Pierce; Jeffrey Terkowitz; J. Rick Turner; Mitchell W. Krucoff; Gregory E. Powell
      Pages: 107 - 115
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Harry A. Seifert, Raleigh E. Malik, Mondira Bhattacharya, Kevin R. Campbell, Sally Okun, Carrie Pierce, Jeffrey Terkowitz, J. Rick Turner, Mitchell W. Krucoff, Gregory E. Powell
      This white paper provides a summary of the presentations and discussions from a think tank on “Enabling Social Listening for Cardiac Safety Monitoring” trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are “missed” by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near–real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.021
      Issue No: Vol. 194 (2017)
       
  • Predicting risk of cardiac events among ST-segment elevation myocardial
           infarction patients with conservatively managed non–infarct-related
           artery coronary artery disease: An analysis of the Duke Databank for
           Cardiovascular Disease
    • Authors: Sameer A. Hirji; Susanna R. Stevens; Linda K. Shaw; Erin C. Campbell; Christopher B. Granger; Manesh R. Patel; Michael H. Sketch; Tracy Y. Wang; E. Magnus Ohman; Eric D. Peterson; J. Matthew Brennan
      Pages: 116 - 124
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Sameer A. Hirji, Susanna R. Stevens, Linda K. Shaw, Erin C. Campbell, Christopher B. Granger, Manesh R. Patel, Michael H. Sketch, Tracy Y. Wang, E. Magnus Ohman, Eric D. Peterson, J. Matthew Brennan
      Background Recent randomized evidence has demonstrated benefit with complete revascularization during the index hospitalization for multivessel coronary artery disease ST-segment elevation myocardial infarction (STEMI) patients; however, this benefit likely depends on the risk of future major adverse cardiovascular events (MACE). Methods Using data from Duke University Medical Center (2003-2012), we identified those at high risk for 1-year MACE among 664 STEMI patients with conservatively managed non–infarct-related artery (non-IRA) lesions. Using multivariable logistic regression, we identified clinical and angiographic characteristics associated with MACE (death, myocardial infarction, urgent revascularization) to 1 year and developed an integer-based risk prediction model for clinical use. Results In this cohort (median age 60 years, 30% female), the unadjusted Kaplan-Meier rates for MACE at 30 days and 1 year were 10% and 28%, respectively. Characteristics associated with MACE at 1 year included reduced left ventricular ejection fraction, hypertension, heart failure, higher-risk non-IRA vessels (left main), renal insufficiency, and greater % stenosis of non-IRA lesions. A 15-point risk score including these variables had modest discrimination (C-index 0.67) across a spectrum of subsequent risk (4%-88%) for 1-year MACE. Conclusions There is a wide spectrum of risk following primary percutaneous coronary intervention for STEMI patients with multivessel disease. Using readily available clinical characteristics, the expected incidence of MACE by 1 year can be calculated with a simplified risk score, facilitating a tailored approach to clinical care.

      PubDate: 2017-10-18T13:26:16Z
      DOI: 10.1016/j.ahj.2017.08.023
      Issue No: Vol. 194 (2017)
       
  • Rational and design of a randomized, double-blind, multicenter trial to
           evaluate the safety and tolerability of furosemide withdrawal in stable
           chronic outpatients with heart failure: The ReBIC-1 trial
    • Authors: Priscila Raupp da Rosa; Luis E. Rohde; Madeni Doebber; Antonio L.P. Ribeiro; Deborah P. Prado; Eduardo G. Bertoldi; Jose A. Figueiredo Neto; Ilmar Kohler; Luis Beck-da-Silva; Luiz C. Danzmann; Lidia Zytynski Moura; Marciane Rover; Marcus V. Simões; Roberto T. Sant'Anna; Andréia Biolo
      Pages: 125 - 131
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Priscila Raupp da Rosa, Luis E. Rohde, Madeni Doebber, Antonio L.P. Ribeiro, Deborah P. Prado, Eduardo G. Bertoldi, Jose A. Figueiredo Neto, Ilmar Kohler, Luis Beck-da-Silva, Luiz C. Danzmann, Lidia Zytynski Moura, Marciane Rover, Marcus V. Simões, Roberto T. Sant'Anna, Andréia Biolo
      Aims Furosemide is commonly prescribed for symptom relief in heart failure (HF) patients. Although few data support the continuous use of loop diuretics in apparently euvolemic HF patients with mild symptoms, there is concern about safety of diuretic withdrawal in these patients. The ReBIC-1 trial was designed to evaluate the safety and tolerability of withdrawing furosemide in stable, euvolemic, chronic HF outpatients. This multicenter initiative is part of the Brazilian Research Network in Heart Failure (ReBIC) created to develop clinical studies in HF and composed predominantly by university tertiary care hospitals. Methods The ReBIC-1 trial is currently enrolling HF patients in NYHA functional class I-II, left ventricular ejection fraction ≤45%, without a HF-related hospital admission within the last 6 months, receiving a stable dose of furosemide (40 or 80 mg per day) for at least 6 months. Eligible patients will be randomized to maintain or withdraw furosemide in a double-blinded protocol. The trial has two co-primary outcomes: (1) dyspnea assessment using a visual-analogue scale evaluated at 4 time points and (2) the proportion of patients maintained without diuretics during the follow-up period. Total sample size was calculated to be 220 patients. Enrolled patients will be followed up to 90 days after randomization, and diuretic will be restarted if clinical deterioration or signs of congestion are detected. Pre-defined sub-group analysis based on NT-proBNP levels at baseline is planned. Perspective Evidence-based strategies aiming to simplify HF pharmacotherapy are needed in clinical practice. The ReBIC-1 trial will determine the safety of withdrawing furosemide in stable chronic HF patients.

      PubDate: 2017-10-18T13:26:16Z
      DOI: 10.1016/j.ahj.2017.08.012
      Issue No: Vol. 194 (2017)
       
  • International trends in clinical characteristics and oral anticoagulation
           treatment for patients with atrial fibrillation: Results from the
           GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries
    • Authors: Benjamin A. Steinberg; Haiyan Gao; Peter Shrader; Karen Pieper; Laine Thomas; A. John Camm; Michael D. Ezekowitz; Gregg C. Fonarow; Bernard J. Gersh; Samuel Goldhaber; Sylvia Haas; Werner Hacke; Peter R. Kowey; Jack Ansell; Kenneth W. Mahaffey; Gerald Naccarelli; James A. Reiffel; Alexander Turpie; Freek Verheugt; Jonathan P. Piccini; Ajay Kakkar; Eric D. Peterson; Keith A.A. Fox
      Pages: 132 - 140
      Abstract: Publication date: December 2017
      Source:American Heart Journal, Volume 194
      Author(s): Benjamin A. Steinberg, Haiyan Gao, Peter Shrader, Karen Pieper, Laine Thomas, A. John Camm, Michael D. Ezekowitz, Gregg C. Fonarow, Bernard J. Gersh, Samuel Goldhaber, Sylvia Haas, Werner Hacke, Peter R. Kowey, Jack Ansell, Kenneth W. Mahaffey, Gerald Naccarelli, James A. Reiffel, Alexander Turpie, Freek Verheugt, Jonathan P. Piccini, Ajay Kakkar, Eric D. Peterson, Keith A.A. Fox
      Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. We aimed to provide comprehensive data on international patterns of AF stroke prevention treatment. Methods Demographics, comorbidities, and stroke risk of the patients in the GARFIELD-AF (n=51,270), ORBIT-AF I (n=10,132), and ORBIT-AF II (n=11,602) registries were compared (overall N=73,004 from 35 countries). Stroke prevention therapies were assessed among patients with new-onset AF (≤6 weeks). Results Patients from GARFIELD-AF were less likely to be white (63% vs 89% for ORBIT-AF I and 86% for ORBIT-AF II) or have coronary artery disease (19% vs 36% and 27%), but had similar stroke risk (85% CHA2DS2-VASc ≥2 vs 91% and 85%) and lower bleeding risk (11% with HAS-BLED ≥3 vs 24% and 15%). Oral anticoagulant use was 46% and 57% for patients with a CHA2DS2-VASc=0 and 69% and 87% for CHA2DS2-VASc ≥2 in GARFIELD-AF and ORBIT-AF II, respectively, but with substantial geographic heterogeneity in use of oral anticoagulant (range: 31%-93% [GARFIELD-AF] and 66%-100% [ORBIT-AF II]). Among patients with new-onset AF, non–vitamin K antagonist oral anticoagulant use increased over time to 43% in 2016 for GARFIELD-AF and 71% for ORBIT-AF II, whereas use of antiplatelet monotherapy decreased from 36% to 17% (GARFIELD-AF) and 18% to 8% (ORBIT-AF I and II). Conclusions Among new-onset AF patients, non–vitamin K antagonist oral anticoagulant use has increased and antiplatelet monotherapy has decreased. However, anticoagulation is used frequently in low-risk patients and inconsistently in those at high risk of stroke. Significant geographic variability in anticoagulation persists and represents an opportunity for improvement.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.08.011
      Issue No: Vol. 194 (2017)
       
  • 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
      Pages: 1 - 7
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      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≥65 years) 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. 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% 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: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.07.020
      Issue No: Vol. 193 (2017)
       
  • 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
      Pages: 8 - 15
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      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 remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation. Methods Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography–detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%). Results 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 (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 transesophageal echocardiography–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, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.07.016
      Issue No: Vol. 193 (2017)
       
  • The relationship of renal function to outcome: A post hoc analysis from
           the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of
           Atrial Fibrillation (ENSURE-AF) study
    • Authors: Gregory Y.H. Lip; Naab Al-Saady; Michael D. Ezekowitz; Maciej Banach; Andreas Goette
      Pages: 16 - 22
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      Author(s): Gregory Y.H. Lip, Naab Al-Saady, Michael D. Ezekowitz, Maciej Banach, Andreas Goette
      The ENSURE-AF study (NCT 02072434) of anticoagulation for electrical cardioversion in nonvalvular atrial fibrillation (NVAF) showed comparable low rates of bleeding and thromboembolism between the edoxaban and the enoxaparin-warfarin treatment arms. This post hoc analysis investigated the relationship between renal function and clinical outcomes. Methods ENSURE-AF was a multicenter, PROBE evaluation trial of edoxaban 60 mg, or dose reduced to 30 mg/d for weight≤60 kg, creatinine clearance (CrCl; Cockcroft-Gault) ≤50 mL/min, or concomitant P-glycoprotein inhibitors compared with therapeutically monitored enoxaparin-warfarin in 2,199 NVAF patients undergoing electrical cardioversion. Efficacy and safety outcomes and time in therapeutic range in the warfarin arm were analyzed in relation to CrCl in prespecified ranges ≥15 and ≤30, >30 and ≤50, >50 and <80, and ≥80 mL/min, and an exploratory ≥95-mL/min analysis. Results A total of 1,095 subjects were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64.3±10 and 64.2±11 years. Mean time in therapeutic range was progressively lower with reducing CrCl strata, being 66.8% in those with CrCl >30 to ≤50 compared with 71.8% in those with CrCl ≥80. The odds ratios for the primary efficacy and safety end points were comparable for the different predefined renal function strata; given the small numbers, the 95% CI included 1.0. In the subset of those with CrCl ≥95, the odds ratios showed consistency with the other CrCl strata. When CrCl was assessed as a continuous variable, there was a nonsignificant trend toward higher major or clinically relevant nonmajor bleeding with reducing CrCl levels, with no significant differences between the 2 treatment arms. When we assessed CrCl at baseline compared with end of treatment, there were no significant differences in CrCl change between the edoxaban and enoxaparin-warfarin arms. The proportions with worsening of renal function (defined as a decrease of >20% from baseline) were similar in the 2 treatment arms. Conclusion Given the small number of events in ENSURE-AF, no effect of renal (dys)function was demonstrated in comparing edoxaban to enoxaparin-warfarin for cardioversion; efficacy and safety of edoxaban remained consistent even in patients with normal or supranormal renal function.

      PubDate: 2017-09-05T18:38:18Z
      DOI: 10.1016/j.ahj.2017.07.010
      Issue No: Vol. 193 (2017)
       
  • Design for the sacubitril/valsartan (LCZ696) compared with enalapril study
           of pediatric patients with heart failure due to systemic left ventricle
           systolic dysfunction (PANORAMA-HF study)
    • Authors: Robert Shaddy; Charles Canter; Nancy Halnon; Lazaros Kochilas; Joseph Rossano; Damien Bonnet; Christopher Bush; Ziqiang Zhao; Paul Kantor; Michael Burch; Fabian Chen
      Pages: 23 - 34
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      Author(s): Robert Shaddy, Charles Canter, Nancy Halnon, Lazaros Kochilas, Joseph Rossano, Damien Bonnet, Christopher Bush, Ziqiang Zhao, Paul Kantor, Michael Burch, Fabian Chen
      Background Sacubitril/valsartan (LCZ696) is an angiotensin receptor neprilysin inhibitor approved for the treatment of adult heart failure (HF); however, the benefit of sacubitril/valsartan in pediatric HF patients is unknown. Study design This global multi-center study will use an adaptive, seamless two-part design. Part 1 will assess the pharmacokinetics/pharmacodynamics of single ascending doses of sacubitril/valsartan in pediatric (1 month to <18 years) HF patients with systemic left ventricle and reduced left ventricular systolic function stratified into 3 age groups (Group 1: 6 to <18 years; Group 2: 1 to <6 years; Group 3: 1 month to <1 year). Part 2 is a 52-week, efficacy and safety study where 360 eligible patients will be randomized to sacubitril/valsartan or enalapril. A novel global rank primary endpoint derived by ranking patients (worst-to-best outcome) based on clinical events such as death, initiation of mechanical life support, listing for urgent heart transplant, worsening HF, measures of functional capacity (NYHA/Ross scores), and patient-reported HF symptoms will be used to assess efficacy. Conclusion The PANORAMA-HF study, which will be the largest prospective pediatric HF trial conducted to date and the first to use a global rank primary endpoint, will determine whether sacubitril/valsartan is superior to enalapril for treatment of pediatric HF patients with reduced systemic left ventricular systolic function.
      Graphical abstract image

      PubDate: 2017-09-05T18:38:18Z
      DOI: 10.1016/j.ahj.2017.07.006
      Issue No: Vol. 193 (2017)
       
  • 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
      Pages: 46 - 54
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      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 4 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 (<60 mL/min/1.73 m2 vs ≥60 mL/min/1.73 m2). The primary outcome was the composite of death or reinfarction at 30 days. Results Of 2,029 patients, 457 (23%) had an eGFR<60 mL/min/1.73 m2. Patients with eGFR<60 mL/min/1.73 m2 were older and had higher Thrombolysis in Myocardial Infarction risk scores. Compared with patients with eGFR≥60 mL/min/1.73 m2, patients with renal dysfunction had higher rates of the primary outcome (5.3% vs 11.8%, respectively; P <.001). There was no significant heterogeneity in the treatment effect of pharmacoinvasive strategy on the primary outcome (P heterogeneity=.73) or the rate of death or reinfarction at 1 year (P heterogeneity=.64) in relation to eGFR. Patients with renal dysfunction had higher rates of in-hospital major bleeding compared with patients with eGFR ≥60 mL/min/1.73 m2 (7.7% vs 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=.67). Conclusions 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: 2017-09-11T08:28:45Z
      DOI: 10.1016/j.ahj.2017.07.015
      Issue No: Vol. 193 (2017)
       
  • 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
      Pages: 55 - 62
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      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 (ASDs) and ventricular septal defects (VSDs). Methods From the Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease—International Study (APPROACH-IS), 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 analysis of covariance. 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. Conclusions 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.

      PubDate: 2017-09-11T08:28:45Z
      DOI: 10.1016/j.ahj.2017.07.019
      Issue No: Vol. 193 (2017)
       
  • Instantaneous wave-free ratio and fractional flow reserve for the
           assessment of nonculprit 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
      Pages: 63 - 69
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      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 lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with 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 (5-8 days 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. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with 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, r 2 =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: 2017-09-16T12:13:05Z
      DOI: 10.1016/j.ahj.2017.07.017
      Issue No: Vol. 193 (2017)
       
  • In-hospital cardiac arrest: Complex clinical challenges in need of unique
           solutions
    • Authors: Angela Lowenstern; Anant Mandawat; L. Kristin Newby
      Pages: 104 - 107
      Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193
      Author(s): Angela Lowenstern, Anant Mandawat, L. Kristin Newby


      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.07.021
      Issue No: Vol. 193 (2017)
       
  • Factors of health in the protection against death and cardiovascular
           disease among adults with subclinical atherosclerosis
    • Authors: Mahmoud Al Rifai; Philip Greenland; Michael J. Blaha; Erin D. Michos; Khurram Nasir; Michael D. Miedema; Joseph Yeboah; Veit Sandfort; Alexis C. Frazier-Wood; Steven Shea; Joao AC Lima; Moyses Szklo; Wendy S. Post; Roger S. Blumenthal; John W. McEvoy
      Abstract: Publication date: Available online 11 November 2017
      Source:American Heart Journal
      Author(s): Mahmoud Al Rifai, Philip Greenland, Michael J. Blaha, Erin D. Michos, Khurram Nasir, Michael D. Miedema, Joseph Yeboah, Veit Sandfort, Alexis C. Frazier-Wood, Steven Shea, Joao AC Lima, Moyses Szklo, Wendy S. Post, Roger S. Blumenthal, John W. McEvoy
      While cardiovascular disease (CVD) prevention traditionally emphasizes risk-factor control, recent evidence also supports the promotion of “health-factors” associated with cardiovascular wellness. However, whether such health-factors exist among adults with advanced subclinical atherosclerosis is unknown. We aimed to study the association between health-factors and events among persons with elevated coronary artery calcium (CAC). Methods and Results Self-reported health-factors studied included non-smoking, physical activity, Mediterranean-style diet, sleep quality, emotional support, low stress burden, and absence of depression. Measured health-factors included optimal weight, blood pressure, lipids, and glucose. Multivariable-adjusted Cox models examined the association between health-factors and incident CVD or mortality, independent of risk-factor treatment. Accelerated failure-time models assessed whether health-factors were associated with relative time-delays in disease onset. Among 1601 Multi-Ethnic Study of Atherosclerosis participants with CAC>100, without baseline clinical ASCVD, mean age was 69 (±9) years, 64% were male, and median CAC score was 332 Agatston-units. Over 12years follow-up, non-smoking, HDL-C levels >40mg/dL for men and >50mg/dL for women, and low stress burden were inversely associated with ASCVD (Hazard Ratios [HRs] ranging from 0.58 to 0.71, all P <.05). Non-smoking, glucose levels <100mg/dL, regular physical activity, and low stress burden were inversely associated with mortality (HRs ranging from 0.40 to 0.77, all P<.05). Each of these factors was also associated with delays in onset of clinical disease, as was absence of depression. Conclusions Adults with elevated CAC appear to have healthy lifestyle options to lower risk and delay onset of CVD, over and above standard preventive therapies.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.026
       
  • Prediction of long-term net clinical outcomes using the TIMI-AF score:
           Comparison with CHA2DS2-VASc and HAS-BLED
    • Authors: José Miguel Rivera-Caravaca; Vanessa Roldán; María Asunción Esteve-Pastor; Mariano Valdés; Vicente Vicente; Francisco Marín; Gregory Y.H. Lip
      Abstract: Publication date: Available online 10 November 2017
      Source:American Heart Journal
      Author(s): José Miguel Rivera-Caravaca, Vanessa Roldán, María Asunción Esteve-Pastor, Mariano Valdés, Vicente Vicente, Francisco Marín, Gregory Y.H. Lip
      Background The TIMI-AF score was described to predict net clinical outcomes (NCOs) in atrial fibrillation (AF) patients receiving warfarin. However, this score derived from the ENGAGE AF-TIMI 48 trial, and no external validation exists in real world clinical practice. We tested the long-term predictive performance of the TIMI-AF score in comparison with CHA2DS2-VASc and HAS-BLED in a ‘real world’ cohort of anticoagulated AF patients. Methods We included 1156 consecutive AF patients stable on vitamin K antagonist (INR 2.0–3.0) during 6months. The baseline risk of NCOs (composite of stroke, life-threatening bleeding, or all-cause mortality) was calculated using the novel TIMI-AF score. During follow-up, all NCOs were recorded and the predictive performance and clinical usefulness of TIMI-AF was compared with CHA2DS2-VASc and HAS-BLED. Results During 6.5years (IQR 4.3–7.9), there were 563 NCOs (7.49%/year). ‘Low’ risk (6.07%/year) and ‘medium’ risk (9.49%/year) patients defined by the TIMI-AF suffered more endpoints that ‘low’ and ‘medium’ risks patients of CHA2DS2-VASc and HAS-BLED (2.37%/year and 4.40%/year for ‘low’ risk; 3.48%/year and 6.39%/year for ‘medium’ risk, respectively). The predictive performance of TIMI-AF was not different from CHA2DS2-VASc (0.678 vs. 0.677, P =.963) or HAS-BLED (0.644 vs. 0.671, P =.054). Discrimination and reclassification did not show improvement of prediction using the TIMI-AF score, and decision curves analysis did not demonstrate higher net benefit. Conclusions In VKA-experienced AF patients, the TIMI-AF score has limited usefulness predicting NCOs over a long-term period of follow-up. This novel score was not superior to CHA2DS2-VASc and HAS-BLED identifying ‘low risk’ AF patients.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.11.004
       
  • Percutaneous Coronary Intervention and Antiplatelet Therapy in Patients
           with Atrial Fibrillation Receiving Apixaban or Warfarin: Insights from the
           ARISTOTLE Trial
    • Authors: David Kopin; W. Schuyler Jones; Matthew W. Sherwood; Daniel M. Wojdyla; Lars Wallentin; Basil S. Lewis; Freek W.A. Verheugt; Dragos Vinereanu; M. Cecilia Bahit; Sigrun Halvorsen; Kurt Huber; Alexander Parkhomenko; Christopher B. Granger; Renato D. Lopes; John H. Alexander
      Abstract: Publication date: Available online 10 November 2017
      Source:American Heart Journal
      Author(s): David Kopin, W. Schuyler Jones, Matthew W. Sherwood, Daniel M. Wojdyla, Lars Wallentin, Basil S. Lewis, Freek W.A. Verheugt, Dragos Vinereanu, M. Cecilia Bahit, Sigrun Halvorsen, Kurt Huber, Alexander Parkhomenko, Christopher B. Granger, Renato D. Lopes, John H. Alexander
      Background We assessed antiplatelet therapy use and outcomes in patients undergoing PCI during the ARISTOTLE trial. Methods Patients were categorized based on the occurrence of PCI during follow-up (median 1.8 years); PCI details and outcomes post-PCI are reported. Of the 18,201 trial participants, 316 (1.7%) underwent PCI (152 in apixaban group, 164 in warfarin group). Results At the time of PCI, 84% (267) were on study drug (either apixaban or warfarin). Of these, 19% did not stop study drug during PCI, 49% stopped and restarted <5 days post-PCI, and 30% stopped and restarted >5 days post-PCI. At 30 days post-PCI, 35% of patients received dual antiplatelet therapy (DAPT), 23% received aspirin only, and 13% received a P2Y12 inhibitor only; 29% received no antiplatelet therapy. Triple therapy (DAPT + oral anticoagulant [OAC]) was used in 21% of patients, 23% received OAC only, 15% received OAC plus aspirin, and 9% received OAC plus a P2Y12 inhibitor; 32% received antiplatelet agents without OAC. Post-PCI, patients assigned to apixaban versus warfarin had numerically similar rates of major bleeding (5.93 vs. 6.73 events/100 patient-years; p=0.95) and stroke (2.74 vs. 1.84 events/100 patient-years; p=0.62). Conclusions PCI occurred infrequently during follow-up. The majority of patients on study drug at the time of PCI remained on study drug in the peri-PCI period; 19% continued the study drug without interruption. Antiplatelet therapy use post-PCI was variable, though the majority of patients received DAPT. Additional data are needed to guide the use of antithrombotics in patients undergoing PCI.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.11.005
       
  • Prognostic value of viral eradication for major adverse cardiovascular
           events in hepatitis C cirrhotic patients
    • Authors: Patrice Cacoub; Pierre Nahon; Richard Layese; Lorraine Blaise; Anne Claire Desbois; Valérie Bourcier; Carole Cagnot; Patrick Marcellin; Dominique Guyader; Stanislas Pol; Dominique Larrey; Victor De Lédinghen; Denis Ouzan; Fabien Zoulim; Dominique Roulot; Albert Tran; Jean-Pierre Bronowicki; Jean-Pierre Zarski; Ghassan Riachi; Paul Calès; Jean-Marie Péron; Laurent Alric; Marc Bourlière; Philippe Mathurin; Jean-Frédéric Blanc; Armand Abergel; Lawrence Serfaty; Ariane Mallat; Jean-Didier Grangé; Pierre Attali; Yannick Bacq; Claire Wartelle; Thông Dao; Dominique Thabut; Christophe Pilette; Christine Silvain; Christos Christidis; Dominique Capron; Gérard Thiefin; David Zucman; Vincent Di Martino; Corinne Isnard Bagnis; Marianne Ziol; Angela Sutton; Eric Letouze; Françoise Roudot-Thoraval; Etienne Audureau
      Abstract: Publication date: Available online 7 November 2017
      Source:American Heart Journal
      Author(s): Patrice Cacoub, Pierre Nahon, Richard Layese, Lorraine Blaise, Anne Claire Desbois, Valérie Bourcier, Carole Cagnot, Patrick Marcellin, Dominique Guyader, Stanislas Pol, Dominique Larrey, Victor De Lédinghen, Denis Ouzan, Fabien Zoulim, Dominique Roulot, Albert Tran, Jean-Pierre Bronowicki, Jean-Pierre Zarski, Ghassan Riachi, Paul Calès, Jean-Marie Péron, Laurent Alric, Marc Bourlière, Philippe Mathurin, Jean-Frédéric Blanc, Armand Abergel, Lawrence Serfaty, Ariane Mallat, Jean-Didier Grangé, Pierre Attali, Yannick Bacq, Claire Wartelle, Thông Dao, Dominique Thabut, Christophe Pilette, Christine Silvain, Christos Christidis, Dominique Capron, Gérard Thiefin, David Zucman, Vincent Di Martino, Corinne Isnard Bagnis, Marianne Ziol, Angela Sutton, Eric Letouze, Françoise Roudot-Thoraval, Etienne Audureau
      Background & Aims The objective was to examine the role of a sustained virological response (SVR) on major adverse cardiovascular events (MACE) in patients with compensated hepatitis C virus (HCV) cirrhosis. Methods Patients with the following criteria were enrolled in 35 French centers a) biopsy-proven HCV cirrhosis; b) Child-Pugh A; c) positive viremia; and d) no prior liver complication, and then prospectively followed. All patients received HCV treatment after inclusion. MACE included stroke, myocardial infarction, ischemic heart disease, heart failure, peripheral arterial disease, cardiac arrest and cardiovascular death. SVR, defined as negative viremia twelve weeks post-treatment, was considered as a time-dependent covariate, and its effect on MACE occurrence was assessed. The median follow up was 57.5months, ending in December 2015. Results 62/878 (7.1%) patients presented a total of 79 MACE. The main predictive baseline factors of MACE were Asian ethnic origin, past history of MACE, arterial hypertension, diabetes mellitus, current smoking, low serum albumin level, high total bilirubin level, and low platelet count. In multivariate analysis, SVR was associated with a decreased risk of MACE (HR=0.35, 95% CI: 0.09; 0.97, P =.044), while Asian ethnic origin, arterial hypertension, smoking and low serum albumin level remained predictive of MACE occurrence. The 5-year survival rate was 60.1% versus 87.5% in patients who did versus those who did not present a MACE (P <.001). Conclusion In patients with compensated HCV-related cirrhosis, Asian ethnic origin, arterial hypertension, smoking and low serum albumin are independent predictive factors of cardiovascular events, while a sustained virological response is associated with a decreased rate of cardiovascular events.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.024
       
  • Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided
           Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate
           Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial
    • Authors: Jeehoon Kang; Bon-Kwon Koo; Xinyang Hu; Joo Myung Lee; Joo-Yong Hahn; Hyoung-Mo Yang; Eun-Seok Shin; Chang-Wook Nam; Joon-Hyung Doh; Bong-Ki Lee; Chul Ahn; JianAn Wang; Seung-Jae Tahk
      Abstract: Publication date: Available online 6 November 2017
      Source:American Heart Journal
      Author(s): Jeehoon Kang, Bon-Kwon Koo, Xinyang Hu, Joo Myung Lee, Joo-Yong Hahn, Hyoung-Mo Yang, Eun-Seok Shin, Chang-Wook Nam, Joon-Hyung Doh, Bong-Ki Lee, Chul Ahn, JianAn Wang, Seung-Jae Tahk
      Background Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. Trial Design Comparison of Fractional FLow Reserve And Intravascular ultrasound guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective randomized clinical trial. A total of 1700 consecutive patients with intermediate stenosis (40–70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the pre-defined criteria for revascularization; FFR ≤0.80 in the FFR-guided group; MLA ≤3mm 2 or [3mm 2 <MLA ≤4 mm 2 and plaque burden >70%] in the IVUS-guided group. The primary endpoint is the patient-oriented composite outcome, which is a composite of all cause death, myocardial infarction and any repeat revascularization at 24months after randomization. We will test non-inferiority of current standard FFR-guided PCI strategy, compared with IVUS-guided decision for PCI and stent optimization strategy. Conclusion The FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.11.001
       
  • Non-Primary PCI at Hospitals without Cardiac Surgery On-Site: Consistent
           Outcomes for All'
    • Authors: Matthew J. Czarny; Julie M. Miller; Daniel Q. Naiman; Chao-Wei Hwang; Rani K. Hasan; Cynthia C. Lemmon; Thomas Aversano
      Abstract: Publication date: Available online 6 November 2017
      Source:American Heart Journal
      Author(s): Matthew J. Czarny, Julie M. Miller, Daniel Q. Naiman, Chao-Wei Hwang, Rani K. Hasan, Cynthia C. Lemmon, Thomas Aversano
      Background The CPORT-E trial showed the non-inferiority of non-primary PCI at hospitals without cardiac surgery on-site (SoS) compared to hospitals with SoS for 6-week mortality and 9-month major adverse cardiac events (MACE). However, target vessel revascularization (TVR) was increased at non-SoS hospitals. Therefore, we aimed to determine the consistency of the Cardiovascular Patient Outcomes Research Team Non-Primary PCI (CPORT-E) trial findings across the spectrum of enrolled patients. Methods Post-hoc subgroup analyses of 6-week mortality and 9-month MACE, defined as the composite of death, Q-wave myocardial infarction, or TVR. Comparison of patients with and without 9-month TVR and rates of related outcomes. Results There was no interaction between SoS status and clinically relevant subgroups for 6-week mortality or 9-month MACE (P for any interaction=0.421 and 0.062, respectively). In addition to increased 9-month rates of TVR and diagnostic catheterization at hospitals without SoS, non-TVR was also increased (2.7% vs 1.9%, P =.002); there was no difference in myocardial infarction-driven TVR, non-TVR, or diagnostic catheterization. Predictors of 9-month TVR included intra-aortic balloon pump use, any index PCI complication, and three-vessel PCI, while predictors of freedom from TVR included SoS, discharge on a P2Y12 inhibitor, and stent implantation. Conclusions The non-inferiority of non-primary PCI at non-SoS hospitals was consistent across clinically relevant subgroups. Elective PCI at an SoS hospital conferred a TVR benefit which may be related to a lower rate of referral for diagnostic catheterization for reasons other than myocardial infarction.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.023
       
  • Representation of Black Patients in Randomized Clinical Trials of Heart
           Failure with Reduced Ejection Fraction
    • Authors: Lonnie T. Sullivan; Tiffany Randolph; Peter Merrill; Larry R. Jackson; Chidiebube Egwim; Monique A. Starks; Kevin L. Thomas
      Abstract: Publication date: Available online 6 November 2017
      Source:American Heart Journal
      Author(s): Lonnie T. Sullivan, Tiffany Randolph, Peter Merrill, Larry R. Jackson, Chidiebube Egwim, Monique A. Starks, Kevin L. Thomas
      Background Black individuals have a disproportionately higher burden of heart failure with reduced ejection fraction (HFrEF) relative to other racial and ethnic populations. We conducted a systematic review to determine the representation, enrollment trends and outcomes of black patients in historic and contemporary randomized clinical trials (RCTs) for HFrEF. Methods We searched PubMed and Embase for RCTs of patients with chronic HFrEF that evaluated therapies that significantly improved clinical outcomes. We extracted trial characteristics and compared them by trial type. Linear regression was used to assess trends in enrollment among HFrEF RCTs over time. Results A total of 25 RCTs, 19 for pharmacotherapies and 6 (N=9,501) for implantable cardioverter defibrillators (ICDs), were included in this analysis. Among these studies, there were 78,816 patients, 4,640 black (5.9%) and the median black participation per trial was 162 patients. Black race was reported in the manuscript of 14 (56.0%) trials and outcomes by race were available for 12 (48.0%) trials. Implantable cardiac defibrillator trials enrolled a greater percentage of black patients than pharmacotherapy trials (7.1% vs. 5.7%). Overall, patient enrollment among the 25 RCTs increased over time (p=0.075); however, the percentage of black patients has decreased (p=0.001). Outcomes varied significantly between black and white patients in 6 studies. Conclusions Black patients are modestly represented among pivotal RCTs of individuals with HFrEF for both pharmacotherapies and ICDs. The current trend for decreasing black representation in trials of HF therapeutics is concerning and must improve to ensure the generalizability for this vulnerable population.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.025
       
  • Rationale and design of the DEAR-OLD trial: randomized evaluation of
           routinely Deferred versus EARly invasive strategy in elderly patients of
           75years or OLDer with non-ST-elevation myocardial infarction
    • Authors: Wenxiu Leng; Jingang Yang; Wei Li; Yang Wang; Yue-Jin Yang
      Abstract: Publication date: Available online 5 November 2017
      Source:American Heart Journal
      Author(s): Wenxiu Leng, Jingang Yang, Wei Li, Yang Wang, Yue-Jin Yang
      Background Comparing with conservative strategy, early invasive approach has been shown to be beneficial for initially stabilized patients with non-ST-elevation myocardial infarction (NSTEMI). However, concerns of increased risk of bleeding and other complications associated with early revascularization in patients aged ≥75years persist. A routinely deferred invasive strategy aiming to facilitate revascularization after stabilizing the culprit lesion predominate across China. Aim To compare efficacy and safety of deferred invasive strategy versus guideline-recommended early invasive strategy in initially stabilized Chinese patients aged ≥75years with NSTEMI. Methods Twenty qualified centers from ten different provinces throughout mainland China will contribute to the study. Eligible patients will be central randomized to a routine deferred invasive approach or an early invasive approach (coronary angiography >72hours or <24hours of admission and appropriate revascularization). Patients meeting the inclusion criteria but not randomized for any reason will be registered. The primary endpoint of the present study is a composite of all-cause mortality, non-lethal (re) MI, ischemic stroke and urgent revascularization at one year. Non-inferiority design is used and the inferiority margin was set to be 5%. The goal is to enroll 696 patients with expected primary endpoint rates of 30%, two-tailed α of 0.05, power of 80%, and drop-out rate of 5%. Conclusions the DEAR-OLD trial is a prospective, nationwide, multi-center, non-inferiority designed, open-label randomized clinical trial evaluating efficacy and safety of routinely deferred invasive strategy compared with early invasive strategy in Chinese elderly patients with NSTEMI.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.022
       
  • Changes in Lipoprotein(a) following Bariatric Surgery
    • Authors: Bing-Xue Lin; Matthew C. Weiss; Manish Parikh; Jeffrey S. Berger; Edward A. Fisher; Sean P. Heffron
      Abstract: Publication date: Available online 4 November 2017
      Source:American Heart Journal
      Author(s): Bing-Xue Lin, Matthew C. Weiss, Manish Parikh, Jeffrey S. Berger, Edward A. Fisher, Sean P. Heffron


      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.020
       
  • Duration of Ischemia and Treatment Effects of Pre- Versus In-Hospital
           Ticagrelor in Patients with ST-Segment Elevation Myocardial Infarction:
           Insights from the ATLANTIC study
    • Authors: Akshay Bagai; Shaun G. Goodman; Warren J. Cantor; Eric Vicaut; Leonardo Bolognese; Angel Cequier; Mohamed Chettibi; Christopher J. Hammett; Kurt Huber; Magnus Janzon; Frédéric Lapostolle; Jens Flensted Lassen; Béla Merkely; Robert F. Storey; Jurriën M. ten Berg; Uwe Zeymer; Abdourahmane Diallo; Christian W. Hamm; Anne Tsatsaris; Jad El Khoury; Arnoud W. van ’t Hof; Gilles Montalescot
      Abstract: Publication date: Available online 4 November 2017
      Source:American Heart Journal
      Author(s): Akshay Bagai, Shaun G. Goodman, Warren J. Cantor, Eric Vicaut, Leonardo Bolognese, Angel Cequier, Mohamed Chettibi, Christopher J. Hammett, Kurt Huber, Magnus Janzon, Frédéric Lapostolle, Jens Flensted Lassen, Béla Merkely, Robert F. Storey, Jurriën M. ten Berg, Uwe Zeymer, Abdourahmane Diallo, Christian W. Hamm, Anne Tsatsaris, Jad El Khoury, Arnoud W. van ’t Hof, Gilles Montalescot
      Background Among patients with STEMI in the ATLANTIC study, pre-hospital administration of ticagrelor improved post-PCI ST-segment resolution and 30-day stent thrombosis. We investigated whether this clinical benefit with pre-hospital ticagrelor differs by ischemic duration. Methods In a post hoc analysis we compared absence of ST-segment resolution post-PCI and stent thrombosis at 30days between randomized treatment groups (pre- versus in-hospital ticagrelor) stratified by symptom onset to first medical contact (FMC) duration [≤1 hr. (n=773), >1 to ≤3 hrs (n=772), and >3 hrs (n=311)], examining the interaction between randomized treatment strategy and duration of symptom onset to FMC for each outcome. Results Patients presenting later after symptom onset were older, more likely to be female, and have higher baseline risk. Patients with symptom onset to FMC >3 hrs had the greatest improvement in post-PCI ST-segment elevation resolution with pre- versus in-hospital ticagrelor (absolute risk difference: ≤1 hr., 2.9% vs. >1 to ≤3 hrs, 3.6% vs. >3 hrs, 12.2%; adjusted p for interaction=0.13), while patients with shorter duration of ischemia had greater improvement in stent thrombosis at 30days with pre- versus in-hospital ticagrelor (absolute risk difference: ≤1 hr., 1.3% vs. >1 hr. to ≤3 hrs, 0.7% vs. >3 hrs, 0.4%; adjusted p for interaction=0.55). Symptom onset to active ticagrelor administration was independently associated with stent thrombosis at 30days (adjusted OR 1.89 per 100minute delay, 95%CI 1.20–2.97, P <.01), but not post-PCI ST-segment resolution (P =.41). Conclusions The effect of pre-hospital ticagrelor to reduce stent thrombosis was most evident when given early within 3hours after symptom onset, with delay in ticagrelor administration after symptom onset associated with higher rate of stent thrombosis. These findings re-emphasize the need for early ticagrelor administration in primary PCI treated STEMI patients.

      PubDate: 2017-11-15T18:52:34Z
      DOI: 10.1016/j.ahj.2017.10.021
       
  • Information for Readers
    • Abstract: Publication date: November 2017
      Source:American Heart Journal, Volume 193


      PubDate: 2017-11-15T18:52:34Z
       
  • Comprehensive Electrocardiogram-to-Device Time for Primary Percutaneous
           Coronary Intervention in ST-segment Elevation Myocardial Infarction: A
           Report from the American Heart Association Mission: Lifeline® Program
    • Authors: Jay S. Shavadia; William French; Anne S. Hellkamp; Laine Thomas; Eric R. Bates; Steven V. Manoukian; Michael C. Kontos; Robert Suter; Timothy D. Henry; Harold L. Dauerman; Matthew T. Roe
      Abstract: Publication date: Available online 2 November 2017
      Source:American Heart Journal
      Author(s): Jay S. Shavadia, William French, Anne S. Hellkamp, Laine Thomas, Eric R. Bates, Steven V. Manoukian, Michael C. Kontos, Robert Suter, Timothy D. Henry, Harold L. Dauerman, Matthew T. Roe
      Background Assessing hospital-related network-level primary percutaneous coronary intervention (PCI) performance for ST-segment elevation myocardial infarction (STEMI) is challenging due to differential time-to-treatment metrics based on location of diagnostic electrocardiogram (ECG) for STEMI. Methods STEMI patients undergoing primary PCI at 588 PCI-capable hospitals in AHA Mission: Lifeline® (2008–2013) were categorized by initial STEMI identification location: PCI-capable hospitals (Group 1); pre-hospital setting (Group 2); and non–PCI-capable hospitals (Group 3). Patient-specific time-to-treatment categories were converted to minutes ahead of or behind their group-specific mean; average time-to-treatment difference for all patients at a given hospital was termed comprehensive ECG-to-device time. Hospitals were then stratified into tertiles based on their comprehensive ECG-to-device times with negative values below the mean representing shorter (faster) time intervals. Results Of 117,857 patients, the proportion in Groups 1, 2, and 3 were 42%, 33%, and 25%, respectively. Lower rates of heart failure and cardiac arrest at presentation are noted within patients presenting to high-performing hospitals. Median comprehensive ECG-to-device time was shortest at −9minutes (25th, 75th percentiles: −13, −6) for the high-performing hospital tertile, 1minute (−1, 3) for middle-performing, and 11minutes for low-performing. Unadjusted rates of in-hospital mortality were 2.3%, 2.6%, and 2.7%, respectively, but the adjusted risk of in-hospital mortality was similar across tertiles. Conclusions Comprehensive ECG-to-device time provides an integrated hospital-related network-level assessment of reperfusion timing metrics for primary PCI, regardless of the location for STEMI identification; further validation will delineate how this metric can be used to facilitate STEMI care improvements.

      PubDate: 2017-11-03T17:24:49Z
      DOI: 10.1016/j.ahj.2017.10.017
       
  • Variation in practice patterns in device closure of atrial septal defects
           and patent ductus arteriosus: An analysis of data from the IMPACT®
           Registry
    • Authors: Michael L O'Byrne; Kevin F Kennedy; Jonathan J Rome; Andrew C Glatz
      Abstract: Publication date: Available online 2 November 2017
      Source:American Heart Journal
      Author(s): Michael L O'Byrne, Kevin F Kennedy, Jonathan J Rome, Andrew C Glatz
      Background Practice variation is a potentially important measure of healthcare quality. The IMPACT® registry provides a representative national sample with which to study practice variation in trans-catheter interventions for congenital heart disease. Methods We studied cases for closure of atrial septal defect (ASD) and patent ductus arteriosus (PDA) in IMPACT® between 1/1/2011 and 9/30/2015, using hierarchical multivariate models studying 1) the distribution of indications for closure and 2) in patients whose indication for closure was left (LVVO) or right ventricular volume overload(RVVO), the factors influencing probability of closure of a small defect (either in size or in terms of the magnitude of shunt). Results Over the study period, 5233 PDA and 4459 ASD cases were performed at 77 hospitals. The indications for ASD closure were RVVO in 84% and stroke prevention in 13%. Indications for PDA closure were LVVO in 57%, endocarditis prevention in 36%, and pulmonary hypertension in 7%. There was statistically significant variability in indications between hospitals for PDA and ASD procedures (median rate ratio (MRR): 1.3 and 1.1; both P <.001). The proportion of cases for volume overload with a Qp:Qs<1.5:1 decreased with increasing PDA and ASD procedural volume (P =.04 and 0.05). For ASD, the proportion was higher at hospitals with a larger proportion of adult cases (P = .0007). There was significant variation in practice in the risk of closing PDA<2 mm for LVVO (MRR: 1.4, P <.001). Conclusion There is measurable variation in transcatheter closure of PDA and ASD. Further research is necessary to study whether this affects outcomes or resource utilization.

      PubDate: 2017-11-03T17:24:49Z
      DOI: 10.1016/j.ahj.2017.10.018
       
  • Primary percutaneous coronary intervention at centers with and without
           on-site surgical support: Insights from the blue cross blue shield of
           Michigan cardiovascular consortium (BMC2)
    • Authors: Majed Afana; Hitinder S. Gurm; Milan Seth; Kathleen M. Frazier; Sheryl Fielding; Gerald C. Koenig
      Abstract: Publication date: Available online 14 October 2017
      Source:American Heart Journal
      Author(s): Majed Afana, Hitinder S. Gurm, Milan Seth, Kathleen M. Frazier, Sheryl Fielding, Gerald C. Koenig
      Background Primary percutaneous coronary intervention (PPCI) is being increasingly performed nationally at sites without on-site cardiac surgery; however, recent guidelines only provide a Class IIa recommendation for this practice. The state of Michigan has permitted PPCI without on-site surgery under a closely monitored system that mandates auditing of all procedures and quarterly feedback on quality and outcomes. Objective This study sought to compare outcomes of patients undergoing PPCI at centers with and without on-site surgery in the state of Michigan. Methods Consecutive patients who underwent PPCI at 47 hospitals in Michigan from January 2010 to December 2015 were included. From this cohort, 4091 patients from sites with and without on-site cardiac surgery were propensity matched in a 1:1 fashion to compare baseline characteristics, procedural details, and in-hospital outcomes. Results Of the 25,886 PPCI's performed at 47 hospitals in Michigan from 2010 to 2015, 21,610 (83.5%) were performed at sites with on-site surgery and 4276 (16.5%) at sites without on-site surgery. Using propensity score matched cohorts (4091 patients for each site type) we found no significant differences in baseline characteristics. Overall mortality (5.4% vs. 5.8%; P =.442), composite outcome of in-hospital mortality, contrast-induced nephropathy, bleeding and stroke (13.8% vs. 12.8%; P =.152), and individual outcomes within the composite group showed no significant differences. Additionally, there were no clinically meaningful differences in rates of urgent/emergent CABG or length of stay. Significant differences, however, were found in procedural access site, antiplatelet therapy, contrast volume, and anticoagulant strategy. Conclusions Primary PCI performed at centers with and without cardiac surgery have comparable outcomes and complication rates, when performed with close monitoring of quality and outcomes.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.10.004
       
  • Role of Doppler Echocardiography for Cardiac Output Assessment in Fontan
           Patients
    • Authors: Alexander Egbe; Arooj R. Khan; Sana F. Khan; Nandan S. Anavekar; Sameh M. Said; Philip M. Young; Emmanuel Akintoye; William R. Miranda; Mohamad N. Al-Otaibi; Gruschen R. Veldtman; Heidi M. Connolly
      Abstract: Publication date: Available online 21 September 2017
      Source:American Heart Journal
      Author(s): Alexander Egbe, Arooj R. Khan, Sana F. Khan, Nandan S. Anavekar, Sameh M. Said, Philip M. Young, Emmanuel Akintoye, William R. Miranda, Mohamad N. Al-Otaibi, Gruschen R. Veldtman, Heidi M. Connolly
      Background To determine: (1) Correlation between Doppler stroke volume index (SVI) and cardiac magnetic resonance imaging (CMRI) SVI: (2) Association between Doppler SVI and Fontan-associated diseases (FAD) and Fontan failure. Methods Review of Fontan patients who underwent same-day CMRI and transthoracic echocardiography (TTE), 2005–2015. We defined FAD as cardiac thrombus, protein-losing enteropathy, arrhythmia, and hospitalization for heart failure. Fontan failure was defined as Fontan conversion or revision, heart transplantation or listing, or death. Results Fifty-three patients with systemic left ventricle (LV) underwent 86 sets of TTE/CMRI. Mean (SD) age 31 (6) years. SVI (45 [16] vs 42 [13] mL/m2), CI (3.0 [1.1] vs 2.8 [0.8] L/minute/m2), and ejection fraction (53 [4]% vs 51 [5]%) were similar for both modalities (P >.05 for all). Doppler SVI correlated with CMRI (r=0.68; P <.001). Sixteen patients had cirrhosis, and these patients had a higher CI (3.9 [0.9] vs 2.8 [1.0] L/minute/m2; P <.01). Among the 37 patients without cirrhosis, Doppler SVI <39mL/m2 was associated with FAD (odds ratio [OR], 2.11; 95% confidence limit, 1.26–3.14; P =.02); Fontan failure was more common in patients with CI was <2.5L/minute/m2 (3/9 [33%] vs 0/28 [0%], P =.01). Another 11 patients with systemic right ventricle (RV) underwent 17 sets of TTE/CMRI, mean (SD) age 17 (3) years, and CMRI SVI also correlated with Doppler SVI (r=0.75; P <.001). Conclusion Doppler SVI correlated with CMRI SVI in patients with systemic LV and systemic RV. The association between output measures (SVI and CI) and FAD were seen only in single LV patients (single RV patients not assessed for this outcome due to small numbers). An association between low Doppler CI and Fontan failure was suggested in a small number of single LV patients.

      PubDate: 2017-10-25T13:40:55Z
      DOI: 10.1016/j.ahj.2017.09.014
       
  • Chocolate consumption and risk of atrial fibrillation: two cohort studies
           and a meta-analysis
    • Authors: Susanna C. Larsson; Nikola Drca; Mats Jensen-Urstad; Alicja Wolk
      Abstract: Publication date: Available online 21 September 2017
      Source:American Heart Journal
      Author(s): Susanna C. Larsson, Nikola Drca, Mats Jensen-Urstad, Alicja Wolk
      Background Chocolate consumption has been inconsistently associated with risk of atrial fibrillation (AF). We investigated the association between chocolate consumption and risk of AF in Swedish adults from two cohort studies and conducted a meta-analysis to summarize available evidence from cohort studies on this topic. Methods Our study population comprised 40,009 men from the Cohort of Swedish Men and 32,486 women from the Swedish Mammography Cohort. Incident AF cases were ascertained through linkage with the Swedish National Patient Register. Published cohort studies of chocolate consumption in relation to risk of AF were identified by a PubMed search through September 14, 2017. Results During a mean follow-up of 14.6years, AF was diagnosed in 9978 Swedish men and women. Compared with non-consumers, the multivariable hazard ratio of AF for those in the highest category of chocolate consumption (≥3–4 servings/week) was 0.96 (95% confidence interval 0.88–1.04). In a random-effects meta-analysis of five cohort studies, including 180,454 participants and 16,356 AF cases, the hazard ratios of AF were 0.97 (95% CI 0.94–1.01) per 2 servings/week increase in chocolate consumption and 0.96 (95% CI 0.90–1.03) for the highest versus lowest category of chocolate consumption. Conclusion Available data provide no evidence of an association of chocolate consumption with risk of AF.

      PubDate: 2017-09-22T12:39:36Z
      DOI: 10.1016/j.ahj.2017.09.013
       
  • 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
       
 
 
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