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Showing 1 - 200 of 3042 Journals sorted alphabetically
AASRI Procedia     Open Access   (Followers: 15)
Academic Pediatrics     Hybrid Journal   (Followers: 19, SJR: 1.402, h-index: 51)
Academic Radiology     Hybrid Journal   (Followers: 16, SJR: 1.008, h-index: 75)
Accident Analysis & Prevention     Partially Free   (Followers: 81, SJR: 1.109, h-index: 94)
Accounting Forum     Hybrid Journal   (Followers: 23, SJR: 0.612, h-index: 27)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 27, SJR: 2.515, h-index: 90)
Achievements in the Life Sciences     Open Access   (Followers: 4)
Acta Anaesthesiologica Taiwanica     Open Access   (Followers: 5, SJR: 0.338, h-index: 19)
Acta Astronautica     Hybrid Journal   (Followers: 325, SJR: 0.726, h-index: 43)
Acta Automatica Sinica     Full-text available via subscription   (Followers: 3)
Acta Biomaterialia     Hybrid Journal   (Followers: 25, SJR: 2.02, h-index: 104)
Acta Colombiana de Cuidado Intensivo     Full-text available via subscription  
Acta de Investigación Psicológica     Open Access   (Followers: 2)
Acta Ecologica Sinica     Open Access   (Followers: 8, SJR: 0.172, h-index: 29)
Acta Haematologica Polonica     Free   (SJR: 0.123, h-index: 8)
Acta Histochemica     Hybrid Journal   (Followers: 3, SJR: 0.604, h-index: 38)
Acta Materialia     Hybrid Journal   (Followers: 204, SJR: 3.683, h-index: 202)
Acta Mathematica Scientia     Full-text available via subscription   (Followers: 5, SJR: 0.615, h-index: 21)
Acta Mechanica Solida Sinica     Full-text available via subscription   (Followers: 9, SJR: 0.442, h-index: 21)
Acta Oecologica     Hybrid Journal   (Followers: 9, SJR: 0.915, h-index: 53)
Acta Otorrinolaringologica (English Edition)     Full-text available via subscription   (Followers: 1)
Acta Otorrinolaringológica Española     Full-text available via subscription   (Followers: 3, SJR: 0.311, h-index: 16)
Acta Pharmaceutica Sinica B     Open Access   (Followers: 2)
Acta Poética     Open Access   (Followers: 4)
Acta Psychologica     Hybrid Journal   (Followers: 22, SJR: 1.365, h-index: 73)
Acta Sociológica     Open Access  
Acta Tropica     Hybrid Journal   (Followers: 5, SJR: 1.059, h-index: 77)
Acta Urológica Portuguesa     Open Access  
Actas Dermo-Sifiliograficas     Full-text available via subscription   (Followers: 4)
Actas Dermo-Sifiliográficas (English Edition)     Full-text available via subscription   (Followers: 3)
Actas Urológicas Españolas     Full-text available via subscription   (Followers: 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: 3)
Ad Hoc Networks     Hybrid Journal   (Followers: 11, SJR: 0.967, h-index: 57)
Addictive Behaviors     Hybrid Journal   (Followers: 15, SJR: 1.514, h-index: 92)
Addictive Behaviors Reports     Open Access   (Followers: 5)
Additive Manufacturing     Hybrid Journal   (Followers: 7, SJR: 1.039, h-index: 5)
Additives for Polymers     Full-text available via subscription   (Followers: 20)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 123, SJR: 5.2, h-index: 222)
Advanced Engineering Informatics     Hybrid Journal   (Followers: 11, SJR: 1.265, h-index: 53)
Advanced Powder Technology     Hybrid Journal   (Followers: 16, SJR: 0.739, h-index: 33)
Advances in Accounting     Hybrid Journal   (Followers: 9, SJR: 0.299, h-index: 15)
Advances in Agronomy     Full-text available via subscription   (Followers: 15, SJR: 2.071, h-index: 82)
Advances in Anesthesia     Full-text available via subscription   (Followers: 25, SJR: 0.169, h-index: 4)
Advances in Antiviral Drug Design     Full-text available via subscription   (Followers: 3)
Advances in Applied Mathematics     Full-text available via subscription   (Followers: 6, SJR: 1.054, h-index: 35)
Advances in Applied Mechanics     Full-text available via subscription   (Followers: 10, SJR: 0.801, h-index: 26)
Advances in Applied Microbiology     Full-text available via subscription   (Followers: 21, SJR: 1.286, h-index: 49)
Advances In Atomic, Molecular, and Optical Physics     Full-text available via subscription   (Followers: 16, SJR: 3.31, h-index: 42)
Advances in Biological Regulation     Hybrid Journal   (Followers: 4, SJR: 2.277, h-index: 43)
Advances in Botanical Research     Full-text available via subscription   (Followers: 3, SJR: 0.619, h-index: 48)
Advances in Cancer Research     Full-text available via subscription   (Followers: 25, SJR: 2.215, h-index: 78)
Advances in Carbohydrate Chemistry and Biochemistry     Full-text available via subscription   (Followers: 9, SJR: 0.9, h-index: 30)
Advances in Catalysis     Full-text available via subscription   (Followers: 5, SJR: 2.139, h-index: 42)
Advances in Cellular and Molecular Biology of Membranes and Organelles     Full-text available via subscription   (Followers: 12)
Advances in Chemical Engineering     Full-text available via subscription   (Followers: 24, SJR: 0.183, h-index: 23)
Advances in Child Development and Behavior     Full-text available via subscription   (Followers: 10, SJR: 0.665, h-index: 29)
Advances in Chronic Kidney Disease     Full-text available via subscription   (Followers: 8, SJR: 1.268, h-index: 45)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 28, SJR: 0.938, h-index: 33)
Advances in Colloid and Interface Science     Full-text available via subscription   (Followers: 18, SJR: 2.314, h-index: 130)
Advances in Computers     Full-text available via subscription   (Followers: 16, SJR: 0.223, h-index: 22)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 11)
Advances in Digestive Medicine     Open Access   (Followers: 4)
Advances in DNA Sequence-Specific Agents     Full-text available via subscription   (Followers: 5)
Advances in Drug Research     Full-text available via subscription   (Followers: 22)
Advances in Ecological Research     Full-text available via subscription   (Followers: 39, SJR: 3.25, h-index: 43)
Advances in Engineering Software     Hybrid Journal   (Followers: 25, SJR: 0.486, h-index: 10)
Advances in Experimental Biology     Full-text available via subscription   (Followers: 7)
Advances in Experimental Social Psychology     Full-text available via subscription   (Followers: 40, SJR: 5.465, h-index: 64)
Advances in Exploration Geophysics     Full-text available via subscription   (Followers: 3)
Advances in Fluorine Science     Full-text available via subscription   (Followers: 8)
Advances in Food and Nutrition Research     Full-text available via subscription   (Followers: 45, SJR: 0.674, h-index: 38)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 14)
Advances in Genetics     Full-text available via subscription   (Followers: 15, SJR: 2.558, h-index: 54)
Advances in Genome Biology     Full-text available via subscription   (Followers: 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: 20, SJR: 0.906, h-index: 24)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 8, SJR: 0.497, h-index: 31)
Advances in Human Factors/Ergonomics     Full-text available via subscription   (Followers: 24)
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: 34, SJR: 4.152, h-index: 85)
Advances in Inorganic Chemistry     Full-text available via subscription   (Followers: 9, SJR: 1.132, h-index: 42)
Advances in Insect Physiology     Full-text available via subscription   (Followers: 3, SJR: 1.274, h-index: 27)
Advances in Integrative Medicine     Hybrid Journal   (Followers: 4)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 4)
Advances in Life Course Research     Hybrid Journal   (Followers: 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: 5, SJR: 0.489, h-index: 25)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 5)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 4, SJR: 1.44, h-index: 51)
Advances in Molecular and Cell Biology     Full-text available via subscription   (Followers: 22)
Advances in Molecular and Cellular Endocrinology     Full-text available via subscription   (Followers: 10)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 7, SJR: 0.324, h-index: 8)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 4)
Advances in Oncobiology     Full-text available via subscription   (Followers: 3)
Advances in Organometallic Chemistry     Full-text available via subscription   (Followers: 15, SJR: 2.885, h-index: 45)
Advances in Parallel Computing     Full-text available via subscription   (Followers: 7, SJR: 0.148, h-index: 11)
Advances in Parasitology     Full-text available via subscription   (Followers: 7, SJR: 2.37, h-index: 73)
Advances in Pediatrics     Full-text available via subscription   (Followers: 21, SJR: 0.4, h-index: 28)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 13)
Advances in Pharmacology     Full-text available via subscription   (Followers: 15, SJR: 1.718, h-index: 58)
Advances in Physical Organic Chemistry     Full-text available via subscription   (Followers: 7, SJR: 0.384, h-index: 26)
Advances in Phytomedicine     Full-text available via subscription  
Advances in Planar Lipid Bilayers and Liposomes     Full-text available via subscription   (Followers: 3, SJR: 0.248, h-index: 11)
Advances in Plant Biochemistry and Molecular Biology     Full-text available via subscription   (Followers: 8)
Advances in Plant Pathology     Full-text available via subscription   (Followers: 5)
Advances in Porous Media     Full-text available via subscription   (Followers: 4)
Advances in Protein Chemistry     Full-text available via subscription   (Followers: 18)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 19, SJR: 1.5, h-index: 62)
Advances in Psychology     Full-text available via subscription   (Followers: 58)
Advances in Quantum Chemistry     Full-text available via subscription   (Followers: 5, SJR: 0.478, h-index: 32)
Advances in Radiation Oncology     Open Access  
Advances in Small Animal Medicine and Surgery     Hybrid Journal   (Followers: 2, SJR: 0.1, h-index: 2)
Advances in Space Research     Full-text available via subscription   (Followers: 338, 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: 6, SJR: 0.823, h-index: 27)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 29, SJR: 1.321, h-index: 56)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 15)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 13)
Advances in Virus Research     Full-text available via subscription   (Followers: 5, SJR: 1.878, h-index: 68)
Advances in Water Resources     Hybrid Journal   (Followers: 43, SJR: 2.408, h-index: 94)
Aeolian Research     Hybrid Journal   (Followers: 5, SJR: 0.973, h-index: 22)
Aerospace Science and Technology     Hybrid Journal   (Followers: 307, 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: 7, SJR: 3.289, h-index: 78)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 422, SJR: 1.385, h-index: 72)
Agri Gene     Hybrid Journal  
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 15, SJR: 2.18, h-index: 116)
Agricultural Systems     Hybrid Journal   (Followers: 30, SJR: 1.275, h-index: 74)
Agricultural Water Management     Hybrid Journal   (Followers: 38, SJR: 1.546, h-index: 79)
Agriculture and Agricultural Science Procedia     Open Access  
Agriculture and Natural Resources     Open Access   (Followers: 1)
Agriculture, Ecosystems & Environment     Hybrid Journal   (Followers: 50, 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: 10, SJR: 0.922, h-index: 66)
Alcoholism and Drug Addiction     Open Access   (Followers: 6)
Alergologia Polska : Polish J. of Allergology     Full-text available via subscription   (Followers: 1)
Alexandria Engineering J.     Open Access   (Followers: 1, SJR: 0.436, h-index: 12)
Alexandria J. of Medicine     Open Access  
Algal Research     Partially Free   (Followers: 8, SJR: 2.05, h-index: 20)
Alkaloids: Chemical and Biological Perspectives     Full-text available via subscription   (Followers: 3)
Allergologia et Immunopathologia     Full-text available via subscription   (Followers: 1, SJR: 0.46, h-index: 29)
Allergology Intl.     Open Access   (Followers: 5, SJR: 0.776, h-index: 35)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 6, SJR: 0.158, h-index: 9)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 46, SJR: 4.289, h-index: 64)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 5)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 3)
American Heart J.     Hybrid Journal   (Followers: 47, SJR: 3.157, h-index: 153)
American J. of Cardiology     Hybrid Journal   (Followers: 44, SJR: 2.063, h-index: 186)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 34, SJR: 0.574, h-index: 65)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 6, SJR: 1.091, h-index: 45)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 15, SJR: 1.653, h-index: 93)
American J. of Human Genetics     Hybrid Journal   (Followers: 30, SJR: 8.769, h-index: 256)
American J. of Infection Control     Hybrid Journal   (Followers: 24, SJR: 1.259, h-index: 81)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 32, SJR: 2.313, h-index: 172)
American J. of Medicine     Hybrid Journal   (Followers: 44, 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: 179, SJR: 2.255, h-index: 171)
American J. of Ophthalmology     Hybrid Journal   (Followers: 54, SJR: 2.803, h-index: 148)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 2)
American J. of Orthodontics and Dentofacial Orthopedics     Full-text available via subscription   (Followers: 6, SJR: 1.249, h-index: 88)
American J. of Otolaryngology     Hybrid Journal   (Followers: 23, SJR: 0.59, h-index: 45)
American J. of Pathology     Hybrid Journal   (Followers: 23, SJR: 2.653, h-index: 228)
American J. of Preventive Medicine     Hybrid Journal   (Followers: 21, SJR: 2.764, h-index: 154)
American J. of Surgery     Hybrid Journal   (Followers: 33, 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: 53, SJR: 0.124, h-index: 9)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 5)
Anales de Cirugia Vascular     Full-text available via subscription  
Anales de Pediatría     Full-text available via subscription   (Followers: 2, SJR: 0.209, h-index: 27)
Anales de Pediatría (English Edition)     Full-text available via subscription  
Anales de Pediatría Continuada     Full-text available via subscription   (SJR: 0.104, h-index: 3)
Analytic Methods in Accident Research     Hybrid Journal   (Followers: 2, SJR: 2.577, h-index: 7)
Analytica Chimica Acta     Hybrid Journal   (Followers: 38, SJR: 1.548, h-index: 152)
Analytical Biochemistry     Hybrid Journal   (Followers: 160, 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: 10)
Anesthésie & Réanimation     Full-text available via subscription  
Anesthesiology Clinics     Full-text available via subscription   (Followers: 21, SJR: 0.421, h-index: 40)
Angiología     Full-text available via subscription   (SJR: 0.124, h-index: 9)
Angiologia e Cirurgia Vascular     Open Access  
Animal Behaviour     Hybrid Journal   (Followers: 152, SJR: 1.907, h-index: 126)
Animal Feed Science and Technology     Hybrid Journal   (Followers: 5, SJR: 1.151, h-index: 83)
Animal Reproduction Science     Hybrid Journal   (Followers: 5, SJR: 0.711, h-index: 78)
Annales d'Endocrinologie     Full-text available via subscription   (SJR: 0.394, h-index: 30)
Annales d'Urologie     Full-text available via subscription  
Annales de Cardiologie et d'Angéiologie     Full-text available via subscription   (SJR: 0.177, h-index: 13)
Annales de Chirurgie de la Main et du Membre Supérieur     Full-text available via subscription  
Annales de Chirurgie Plastique Esthétique     Full-text available via subscription   (Followers: 2, SJR: 0.354, h-index: 22)
Annales de Chirurgie Vasculaire     Full-text available via subscription   (Followers: 1)

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Journal Cover American Heart Journal
  [SJR: 3.157]   [H-I: 153]   [47 followers]  Follow
   Hybrid Journal Hybrid journal (It can contain Open Access articles)
   ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
   Published by Elsevier Homepage  [3042 journals]
  • High-sensitivity C-reactive protein is an independent marker of abnormal
           coronary vasoreactivity in patients with non-obstructive coronary artery
    • Authors: Jaskanwal D.S. Sara; Megha Prasad; Ming Zhang; Ryan J. Lennon; Joerg Herrmann; Lilach O. Lerman; Amir Lerman
      Pages: 1 - 11
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Jaskanwal D.S. Sara, Megha Prasad, Ming Zhang, Ryan J. Lennon, Joerg Herrmann, Lilach O. Lerman, Amir Lerman
      Background Coronary endothelial dysfunction (CED) is an early stage of atherosclerosis and is associated with adverse cardiovascular events. Inflammation may play a role in the development of endothelial dysfunction. To date no study has evaluated the relationship between C-reactive protein and CED. We aimed to determine if C-reactive protein is associated with CED. Methods In 1016 patients (mean age 50.7±12.3 years, 34% male) presenting to the catheterization laboratory with chest pain and non-obstructive coronary artery disease, coronary vasoreactivity was assessed by measuring the percent change in coronary blood flow (%ΔCBF) and coronary artery diameter (%ΔCAD) in response to intracoronary acetylcholine. Plasma high sensitivity C-reactive protein (hs-CRP) was measured and patients were divided into 2 groups: hs-CRP≤3.0 mg/L (low-intermediate cardiovascular risk n=169) and 3 mg/L<hs-CRP≤10 mg/L (high cardiovascular risk n=847). Results Patients with a high risk hs-CRP had a significantly lower %ΔCBF and %ΔCAD in response to acetylcholine vs low risk hs-CRP (43.8±6.1 vs 65.8±4.5, P =.004 and −17.2±1.5 vs −13.1±0.8, P =.02 respectively). Low risk hs-CRP was associated with significantly higher %ΔCBF and %ΔCAD vs high risk hs-CRP (27.1±11.0, P =.01 and 4.5±1.9, P =.02 respectively). CED was associated with significantly higher hs-CRP levels and high risk hs-CRP was independently associated with abnormal coronary vasoreactivity, OR 1.82 (95% CI 1.25–2.69). Conclusions Hs-CRP is independently associated with and a strong predictor of abnormal coronary vasoreactivity in patients with non-obstructive coronary artery disease.

      PubDate: 2017-05-24T14:33:48Z
      DOI: 10.1016/j.ahj.2017.02.035
      Issue No: Vol. 190 (2017)
  • Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF)
           randomized trial: Design and rationale
    • Authors: Richard A. Bernstein; Hooman Kamel; Christopher B. Granger; Robert C. Kowal; Paul D. Ziegler; Lee H. Schwamm
      Pages: 19 - 24
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Richard A. Bernstein, Hooman Kamel, Christopher B. Granger, Robert C. Kowal, Paul D. Ziegler, Lee H. Schwamm
      Background Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the STROKE-AF trial. Study design STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10 days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12 months and up to 3 years. Outcomes The primary objective is to compare the incidence rate of detected AF through 12 months of follow-up between the two arms. Conclusion This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention.

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

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

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.002
      Issue No: Vol. 190 (2017)
  • Clinical outcomes with percutaneous coronary revascularization vs coronary
           artery bypass grafting surgery in patients with unprotected left main
           coronary artery disease: A meta-analysis of 6 randomized trials and 4,686
    • Authors: Tullio Palmerini; Patrick Serruys; Arie Pieter Kappetein; Philippe Genereux; Diego Della Riva; Letizia Bacchi Reggiani; Evald Christiansen; Niels R. Holm; Leif Thuesen; Timo Makikallio; Marie Claude Morice; Jung-Min Ahn; Seung-Jung Park; Holger Thiele; Enno Boudriot; Mario Sabatino; Mattia Romanello; Giuseppe Biondi-Zoccai; Raphael Cavalcante; Joseph F. Sabik; Gregg W. Stone
      Pages: 54 - 63
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Tullio Palmerini, Patrick Serruys, Arie Pieter Kappetein, Philippe Genereux, Diego Della Riva, Letizia Bacchi Reggiani, Evald Christiansen, Niels R. Holm, Leif Thuesen, Timo Makikallio, Marie Claude Morice, Jung-Min Ahn, Seung-Jung Park, Holger Thiele, Enno Boudriot, Mario Sabatino, Mattia Romanello, Giuseppe Biondi-Zoccai, Raphael Cavalcante, Joseph F. Sabik, Gregg W. Stone
      Some but not all randomized controlled trials (RCT) have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative to coronary artery bypass grafting (CABG) surgery for the treatment of unprotected left main coronary artery disease (ULMCAD). We therefore aimed to compare the risk of all-cause mortality between PCI and CABG in patients with ULMCAD in a pairwise meta-analysis of RCT. Methods Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Results Six trials including 4,686 randomized patients were identified. After a median follow-up of 39 months, there were no significant differences between PCI vs CABG in the risk of all-cause mortality (hazard ratio [HR] 0.99, 95% CI 0.76-1.30) or cardiac mortality. However, a significant interaction for cardiac mortality (P interaction= .03) was apparent between randomization arm and SYNTAX score, such that the relative risk for mortality tended to be lower with PCI compared with CABG among patients in the lower SYNTAX score tertile, similar in the intermediate tertile, and higher in the upper SYNTAX score tertile. Percutaneous coronary intervention compared with CABG was associated with a similar long-term composite risk of death, myocardial infarction, or stroke (HR 1.06, 95% CI 0.82-1.37), with fewer events within 30 days after PCI offset by fewer events after 30 days with CABG (P interaction < .0001). Percutaneous coronary intervention was associated with greater rates of unplanned revascularization compared with CABG (HR 1.74, 95% CI 1.47-2.07). Conclusions In patients undergoing revascularization for ULMCAD, PCI was associated with similar rates of mortality compared with CABG at a median follow-up of 39 months, but with an interaction effect suggesting relatively lower mortality with PCI in patients with low SYNTAX score and relatively lower mortality with CABG in patients with high SYNTAX score. Both procedures resulted in similar long-term composite rates of death, myocardial infarction, or stroke, with PCI offering an early safety advantage and CABG demonstrating greater durability.

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

      PubDate: 2017-06-04T14:51:09Z
      DOI: 10.1016/j.ahj.2017.05.007
      Issue No: Vol. 190 (2017)
  • Effects of serelaxin on the outcome of patients with or without
           substantial peripheral edema: A subgroup analysis from the RELAX-AHF trial
    • Authors: Claudio Gimpelewicz; Marco Metra; John G.F Cleland; Peter Szecsödy; Chuan-Chuan Chang Wun; Leandro Boer-Martins; Gad Cotter; Beth A. Davison; Gary Michael Felker; Gerasimos Filippatos; Barry H. Greenberg; Peter Pang; Piotr Ponikowski; Thomas Severin; Adrian A. Voors; John R. Teerlink
      Pages: 113 - 122
      Abstract: Publication date: August 2017
      Source:American Heart Journal, Volume 190
      Author(s): Claudio Gimpelewicz, Marco Metra, John G.F Cleland, Peter Szecsödy, Chuan-Chuan Chang Wun, Leandro Boer-Martins, Gad Cotter, Beth A. Davison, Gary Michael Felker, Gerasimos Filippatos, Barry H. Greenberg, Peter Pang, Piotr Ponikowski, Thomas Severin, Adrian A. Voors, John R. Teerlink
      Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5%) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5%). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.

      PubDate: 2017-06-18T16:55:11Z
      DOI: 10.1016/j.ahj.2017.05.012
      Issue No: Vol. 190 (2017)
  • When academic research organizations and clinical research organizations
           disagree: Processes to minimize discrepancies prior to unblinding of
           randomized trials
    • Authors: C. Michael Gibson; Samuel Z. Goldhaber; Alexander T. Cohen; Tarek Nafee; Adrian F. Hernandez; Russell Hull; Serge Korjian; Yazan Daaboul; Gerald Chi; Megan Yee; Robert A. Harrington
      Pages: 1 - 8
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): C. Michael Gibson, Samuel Z. Goldhaber, Alexander T. Cohen, Tarek Nafee, Adrian F. Hernandez, Russell Hull, Serge Korjian, Yazan Daaboul, Gerald Chi, Megan Yee, Robert A. Harrington

      PubDate: 2017-04-13T20:33:33Z
      DOI: 10.1016/j.ahj.2017.03.018
      Issue No: Vol. 189 (2017)
  • Hemodynamic determinants of mortality after Fontan operation
    • Authors: Hideo Ohuchi; Aya Miyazaki; Jun Negishi; Yosuke Hayama; Michikazu Nakai; Kunihiro Nishimura; Hajime Ichikawa; Isao Shiraishi; Osamu Yamada
      Pages: 9 - 18
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Hideo Ohuchi, Aya Miyazaki, Jun Negishi, Yosuke Hayama, Michikazu Nakai, Kunihiro Nishimura, Hajime Ichikawa, Isao Shiraishi, Osamu Yamada
      Background Elevated central venous pressure (CVP), low cardiac output, and mild hypoxia are common early and late after Fontan operations. However, the association of these characteristics with late mortality is unclear. We aimed to elucidate the hemodynamic determinants of mortality after Fontan operation. Method We evaluated early (group early; 0.5-5years postoperatively, n=387) and late (group late; ≥15years postoperatively, n=161) Fontan hemodynamics that included CVP (mm Hg), cardiac index (CI; L/min per m2), systemic ventricular end-diastolic volume index (mL/m2), ejection fraction (EF; %), and arterial blood oxygen saturation (%). We examined the effect of these variables on 5-year all-cause mortality. Results Mortality was higher in group late than in group early (17 vs 11, P <.0001). In both groups, higher CVP (hazard ratio [HR]1.46 and 1.38, respectively; P <.001-.0001) and lower arterial blood oxygen saturation (HR 1.12, P <.001 for both) were associated with increased mortality. Greater end-diastolic volume index (HR per 20: 1.73) and lower EF (HR per 10%: 3.38) were associated with increased mortality only in group early (P <.0001 for both). In contrast, only in group late was higher CI associated with increased mortality (HR 2.50, 95% CI 1.30-4.55, P <.01). Seven patients in group late with both high CVP (≥14) and CI (≥3.0) had the highest mortality (HR 18.1, 5.55-52.4, P <.0001). Conclusions Elevated CVP and low arterial blood oxygen saturation correlate with mortality in both early and late Fontan survivors. End-diastolic volume index and EF are associated with mortality only in the earlier cohort, whereas interestingly, elevated cardiac output is associated with increased mortality in the later cohort.

      PubDate: 2017-04-27T20:51:26Z
      DOI: 10.1016/j.ahj.2017.03.020
      Issue No: Vol. 189 (2017)
  • Electrocardiographic abnormalities and mortality in aging survivors of
           childhood cancer: A report from the St Jude Lifetime Cohort Study
    • Authors: Daniel A. Mulrooney; Elsayed Z. Soliman; Matthew J. Ehrhardt; Lu Lu; Daniel A. Duprez; Russell V. Luepker; Gregory T. Armstrong; Vijaya M. Joshi; Daniel M. Green; Deokumar Srivastava; Matthew J. Krasin; G. Stephen Morris; Leslie L. Robison; Melissa M. Hudson; Kirsten K. Ness
      Pages: 19 - 27
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Daniel A. Mulrooney, Elsayed Z. Soliman, Matthew J. Ehrhardt, Lu Lu, Daniel A. Duprez, Russell V. Luepker, Gregory T. Armstrong, Vijaya M. Joshi, Daniel M. Green, Deokumar Srivastava, Matthew J. Krasin, G. Stephen Morris, Leslie L. Robison, Melissa M. Hudson, Kirsten K. Ness
      Background Electrocardiography (ECG), predictive of adverse outcomes in the general population, has not been studied in cancer survivors. We evaluated the prevalence of ECG abnormalities and associations with mortality among childhood cancer survivors. Methods Major and minor abnormalities were coded per the Minnesota Classification system for participants in the St Jude Lifetime Cohort Study (n = 2,715) and community controls (n = 268). Odds ratios (ORs) and 95% CIs were calculated using multivariable logistic regression; and hazard ratios, using Cox proportional hazards regression. Results Survivors were a median age of 31.3 (range 18.4-63.8) years at evaluation and 7.4 (range 0-24.8) years at diagnosis. Prior therapies included cardiac-directed radiation (29.5%), anthracycline (57.9%), and alkylating (60%) chemotherapies. The prevalence of minor ECG abnormalities was similar among survivors and controls (65.2% vs 67.5%, P = .6). Major ECG abnormalities were identified in 10.7% of survivors and 4.9% of controls (P < .001). Among survivors, the most common major abnormalities were isolated ST/T wave abnormalities (7.2%), evidence of myocardial infarction (3.7%), and left ventricular hypertrophy with strain pattern (2.8%). Anthracyclines ≥300 mg/m2 (OR 1.7 95% CI 1.1-2.5) and cardiac radiation (OR 2.1 95% CI 1.5-2.9 [1-1,999 cGy], 2.6 95% CI 1.6-3.9 [2,000-2,999 cGy], 10.5 95% CI 6.5-16.9 [≥3,000 cGy]) were associated with major abnormalities. Thirteen participants had a cardiac-related death. Major abnormalities were predictive of all-cause mortality (hazard ratio 4.0 95% CI 2.1-7.8). Conclusions Major ECG abnormalities are common among childhood cancer survivors, associated with increasing doses of anthracyclines and cardiac radiation, and predictive of both cardiac and all-cause mortality.

      PubDate: 2017-04-27T20:51:26Z
      DOI: 10.1016/j.ahj.2017.03.023
      Issue No: Vol. 189 (2017)
  • Impact of continuous positive airway pressure and oxygen on health status
           in patients with coronary heart disease, cardiovascular risk factors, and
           obstructive sleep apnea: A Heart Biomarker Evaluation in Apnea Treatment
           (HEARTBEAT) analysis
    • Authors: Eldrin F. Lewis; Rui Wang; Naresh Punjabi; Daniel J. Gottlieb; Stuart F. Quan; Deepak L. Bhatt; Sanjay R. Patel; Reena Mehra; Roger S. Blumenthal; Jia Weng; Michael Rueschman; Susan Redline
      Pages: 59 - 67
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Eldrin F. Lewis, Rui Wang, Naresh Punjabi, Daniel J. Gottlieb, Stuart F. Quan, Deepak L. Bhatt, Sanjay R. Patel, Reena Mehra, Roger S. Blumenthal, Jia Weng, Michael Rueschman, Susan Redline
      Introduction Obstructive sleep apnea (OSA) is associated with impaired health-related quality of life (HRQL). Treatment with continuous positive airway pressure (CPAP) has variable impacts on HRQL, and this may be influenced by patient's tolerance of therapy. The objective is to determine the impact of nocturnal supplemental oxygen (NSO) and CPAP on HRQL compared with healthy lifestyle education (HLSE) in individuals with OSA. Methods Patients with coronary heart disease (CHD) or at least 3 major CHD risk factors with apnea-hypopnea index of 15 to 50 events/h were randomized to CPAP, NSO, or HLSE. Health-related quality of life was assessed using the Short-Form 36, and depression was assessed with Patient Health Questionnaire-9 at baseline and 12 weeks. The treatment effect on HRQL change scores through 12 weeks was assessed using multivariable models adjusting for study site, presence of CHD at baseline, race, and baseline HRQL. Results A total of 318 patients were randomized to 1 of 3 treatment arms with 1:1:1 ratio and 94% completed baseline and follow-up HRQL instruments. Mean Short-Form 36 scores were similar at baseline in all 3 groups ranging from 41.8±12 to 51.6±12 in various domains. In multivariable models, the CPAP group noted a significantly greater improvement than NSO in mental health (+2.33, 95% CI 0.34-4.31, P =.02) and mental composite score (+2.40, 95% CI 0.40-4.41, P =.02). Conversely, the CPAP group noted less improvement than NSO in physical function (−2.68, 95% CI −4.66 to −0.70, P =.008) and physical composite score (−2.17, 95% CI −3.82 to −0.51, P =.01). Compared with HLSE, vitality and Patient Health Questionnaire-9 improved with CPAP but not with NSO. Significant interactions were noted between treatment effects with larger differences in black and sleepy patients. Conclusion These data support the use of CPAP for improving vitality, sleepiness, mental health, social functioning, and depressive symptoms in patients with OSA and established CHD or risk factors. Nocturnal supplemental oxygen may have beneficial effects on perceived physical functioning.

      PubDate: 2017-05-04T12:08:37Z
      DOI: 10.1016/j.ahj.2017.03.001
      Issue No: Vol. 189 (2017)
  • The Assessment of the Watchman Device in Patients Unsuitable for Oral
           Anticoagulation (ASAP-TOO) trial
    • Authors: David R. Holmes; Vivek Y. Reddy; Maurice Buchbinder; Kenneth Stein; Myriah Elletson; Martin W. Bergmann; Boris Schmidt; Jacqueline Saw
      Pages: 68 - 74
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): David R. Holmes, Vivek Y. Reddy, Maurice Buchbinder, Kenneth Stein, Myriah Elletson, Martin W. Bergmann, Boris Schmidt, Jacqueline Saw
      Background Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial. Study objectives The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC. The primary effectiveness end point is the time to first occurrence of ischemic stroke or systemic embolism. The primary safety end point includes all-cause death, ischemic stroke, systemic embolism, or device- or procedural-related event requiring open cardiac surgery or major endovascular intervention. Study design This is a multinational, multicenter prospective randomized trial. Patients meeting the inclusion criteria with CHA2DS2-VASc score≥2 and who are deemed by 2 study physicians to be unsuitable for OAC will be randomized in a 2:1 allocation ratio to Watchman versus control. Control patients will be prescribed single antiplatelet therapy or no therapy at the discretion of the study physician. Up to 888 randomized subjects will be enrolled from up to 100 global investigational sites. Both device group and control patients will have follow-up visits at 3, 6, and 12months and then every 6months through 60months. Summary This trial will assess the safety and efficacy of Watchman in this challenging population of high–stroke risk AF patients.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.03.007
      Issue No: Vol. 189 (2017)
  • Effects of implantable cardioverter/defibrillator shock and
           antitachycardia pacing on anxiety and quality of life: A MADIT-RIT
    • Authors: Alessandro Paoletti Perini; Valentina Kutyifa; Peter Veazie; James P. Daubert; Claudio Schuger; Wojciech Zareba; Scott McNitt; Spencer Rosero; Christine Tompkins; Luigi Padeletti; Arthur J. Moss
      Pages: 75 - 84
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Alessandro Paoletti Perini, Valentina Kutyifa, Peter Veazie, James P. Daubert, Claudio Schuger, Wojciech Zareba, Scott McNitt, Spencer Rosero, Christine Tompkins, Luigi Padeletti, Arthur J. Moss
      Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. Methods We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial—Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates. Results In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P <.01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P =.005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P =.028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P =.997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). Conclusions In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.03.009
      Issue No: Vol. 189 (2017)
  • Seasonal and circadian variations of acute myocardial infarction: Findings
           from the Get With The Guidelines–Coronary Artery Disease (GWTG-CAD)
    • Authors: Vijaiganesh Nagarajan; Gregg C. Fonarow; Christine Ju; Michael Pencina; Warren K. Laskey; Thomas M. Maddox; Adrian Hernandez; Deepak L. Bhatt
      Pages: 85 - 93
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Vijaiganesh Nagarajan, Gregg C. Fonarow, Christine Ju, Michael Pencina, Warren K. Laskey, Thomas M. Maddox, Adrian Hernandez, Deepak L. Bhatt
      Background Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST-segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. We also investigated the peak time of admission to better understand the circadian rhythm. Methods Data from the GWTG-CAD database were used. We analyzed 82,971 consecutive acute myocardial infarction (AMI) patients treated at 276 US centers from 2003 to 2008. The country was geographically divided into warmer southern and colder northern states using latitude 35 degrees for this purpose. Results Overall, acute myocardial infarction (AMI) admissions varied across seasons (P < .01), and were higher in winter (winter vs. spring n = 21,483 vs. 20,291, respectively). When stratified based on type of AMI, non–ST-segment elevation myocardial infarction (NSTEMI) admissions varied across seasons (P < .01) and were highest in winter and lowest in spring. Seasonal variation was not significant in STEMI admissions (P = .30). Seasonal variation with winter predominance was noted in AMI patients in warmer southern states (P < .01), but not in colder states. The distributions of length of stay for AMI patients and door to balloon times for STEMI patients were minimally different across all four seasons (P < .01) with longest occurring in winter. Most patients with AMI presented during daytime with a peak close to 11 am and a nadir at approximately 4 am. Conclusions Seasonal variation with winter predominance exists in AMI admissions and was significant in NSTEMI admissions but not in STEMI admissions. Seasonal variation was only significant in warmer southern states.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.04.002
      Issue No: Vol. 189 (2017)
  • Design and rationale for the Influenza vaccination After Myocardial
           Infarction (IAMI) trial. A registry-based randomized clinical trial
    • Authors: Ole Fröbert; Matthias Götberg; Oskar Angerås; Lena Jonasson; David Erlinge; Thomas Engstrøm; Jonas Persson; Svend E. Jensen; Elmir Omerovic; Stefan K. James; Bo Lagerqvist; Johan Nilsson; Amra Kåregren; Rasmus Moer; Cao Yang; David B. Agus; Andrejs Erglis; Lisette O. Jensen; Lars Jakobsen; Evald H. Christiansen; John Pernow
      Pages: 94 - 102
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Ole Fröbert, Matthias Götberg, Oskar Angerås, Lena Jonasson, David Erlinge, Thomas Engstrøm, Jonas Persson, Svend E. Jensen, Elmir Omerovic, Stefan K. James, Bo Lagerqvist, Johan Nilsson, Amra Kåregren, Rasmus Moer, Cao Yang, David B. Agus, Andrejs Erglis, Lisette O. Jensen, Lars Jakobsen, Evald H. Christiansen, John Pernow
      Background Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. Methods/design The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. Implications The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.04.003
      Issue No: Vol. 189 (2017)
  • Impact of AHA’s 2007 guideline change on incidence of infective
           endocarditis in infants and children
    • Authors: Rie Sakai Bizmark; Ruey-Kang R. Chang; Yusuke Tsugawa; Kenneth M. Zangwill; Ichiro Kawachi
      Pages: 110 - 119
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Rie Sakai Bizmark, Ruey-Kang R. Chang, Yusuke Tsugawa, Kenneth M. Zangwill, Ichiro Kawachi
      Use a nationally representative sample to assess impacts of new clinical guidelines issued by the American Heart Association (AHA) in 2007 for many types of invasive procedures, with recommendations for significant decreases in antimicrobial prophylaxis use. Study design Interrupted time series analyses of pediatric hospitalizations for Infective Endocarditis (IE), using the Nationwide Inpatient Sample (NIS) ICD-9-CM diagnostic codes, identified IE hospitalizations for patients <18 years old from 2001 to 2012. Changes in IE incidence before and after 2007 AHA guidelines were evaluated, with differences in IE clinical severity assessed using in-hospital mortality and length of stay. Analyses were stratified by pathogen type and age group (0–9 y/o and 10–17 y/o). Results With 3,748 patients in the study, we observed rising trends in IE incidence, but no significant difference between pre- and post-guideline. There was a significant trend increase for IE due to viridans group streptococci (VGS) for ages >10 years old, comparing pre-guideline to post-guideline periods, but not in children 0–9 years of age. Neither in-hospital mortality nor length of stay changed significantly during study. Conclusions The data did not demonstrate an impact of the 2007 guideline changes on overall incidence of pediatric IE. However, a significant increase in disease incidence trend due to VGS was observed for the 10–17 year-old group, compared pre- and post-guideline.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.04.006
      Issue No: Vol. 189 (2017)
  • Effect of aspirin on renal disease progression in patients with type 2
           diabetes: A multicenter, double-blind, placebo-controlled, randomized
           trial. The renaL disEase progression by aspirin in diabetic pAtients
           (LEDA) trial. Rationale and study design
    • Authors: Francesco Violi; Giovanni Targher; Annarita Vestri; Roberto Carnevale; Maurizio Averna; Alessio Farcomeni; Andrea Lenzi; Francesco Angelico; Francesco Cipollone; Daniele Pastori
      Pages: 120 - 127
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Francesco Violi, Giovanni Targher, Annarita Vestri, Roberto Carnevale, Maurizio Averna, Alessio Farcomeni, Andrea Lenzi, Francesco Angelico, Francesco Cipollone, Daniele Pastori
      Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0-2.5mL min−1 y−1. Cyclooxygenase-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx)B2, are increased in T2DM patients and are potentially involved in the regulation of renal blood flow. Animal models showed that cyclooxygenase inhibitors, such as aspirin, are associated with improvements in renal plasma flow and eGFR values. Hypothesis The primary end point of the LEDA trial is to evaluate the 1-year decline of eGFR in T2DM patients treated or not with low-dose aspirin (100mg/d). Secondary end points will be the rapid decline in renal function, defined as a reduction of eGFR ≥5mL/min, and change of renal function class after 1-year follow-up. Furthermore, urinary excretion 11-dehydro-TxB2 will be related to renal function modifications. Study design A phase 3 no-profit, multicenter, double-blind, randomized intervention trial of aspirin 100mg/dvs placebo ( Identifier: NCT02895113). All patients will be monitored at 6 and 12months after randomization to assess drug adherence and eGFR changes. Summary The LEDA trial is the first double-blind, placebo-controlled, randomized clinical trial aimed at examining whether aspirin treatment may beneficially affect kidney function in patients with T2DM by reducing the annual eGFR decline. The trial will also examine whether the potential renoprotective effects of aspirin might be partly due to its inhibition of TxB2 production.

      PubDate: 2017-05-09T14:10:27Z
      DOI: 10.1016/j.ahj.2017.04.005
      Issue No: Vol. 189 (2017)
  • Rationale and design of the Hunting for the off-target propertIes of
           Ticagrelor on Endothelial function and other Circulating biomarkers in
           Humans (HI-TECH) trial
    • Authors: Sara Ariotti; Maarten van Leeuwen; Salvatore Brugaletta; Sergio Leonardi; Kristiaan Martijn Akkerhuis; Emrush Rexhaj; Gladys Janssens; Luis Ortega-Paz; Diego Rizzotti; Jan C. van den Berge; Dierik Heg; Gloria Francolini; Stephan Windecker; Marco Valgimigli
      Pages: 128 - 136
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Sara Ariotti, Maarten van Leeuwen, Salvatore Brugaletta, Sergio Leonardi, Kristiaan Martijn Akkerhuis, Emrush Rexhaj, Gladys Janssens, Luis Ortega-Paz, Diego Rizzotti, Jan C. van den Berge, Dierik Heg, Gloria Francolini, Stephan Windecker, Marco Valgimigli
      Background Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels. Methods The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order. The primary objective was to evaluate whether ticagrelor, at treatment steady state (ie, after 30 ± 5 days of drug administration), as compared with both clopidogrel and prasugrel, is associated with an improved endothelial function, assessed with peripheral arterial tonometry. Thirty-six patients undergoing evaluable endothelial function assessment for each of the assigned P2Y12 inhibitor were needed to provide 90% power to detect a 10% relative change of the reactive hyperemia index in the ticagrelor group. Conclusion The HI-TECH study is the first randomized, crossover study aiming to ascertain whether ticagrelor, when administered at approved regimen in post-ACS patients, improves endothelial function as compared with both clopidogrel and prasugrel.

      PubDate: 2017-06-18T16:55:11Z
      DOI: 10.1016/j.ahj.2017.03.017
      Issue No: Vol. 189 (2017)
  • Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism
           in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
           (ARTESiA) trial
    • Authors: Renato D. Lopes; Marco Alings; Stuart J. Connolly; Heather Beresh; Christopher B. Granger; Juan Benezet Mazuecos; Giuseppe Boriani; Jens C. Nielsen; David Conen; Stefan H. Hohnloser; Georges H. Mairesse; Philippe Mabo; A. John Camm; Jeffrey S. Healey
      Pages: 137 - 145
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Renato D. Lopes, Marco Alings, Stuart J. Connolly, Heather Beresh, Christopher B. Granger, Juan Benezet Mazuecos, Giuseppe Boriani, Jens C. Nielsen, David Conen, Stefan H. Hohnloser, Georges H. Mairesse, Philippe Mabo, A. John Camm, Jeffrey S. Healey
      Background Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Design ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic embolism. Approximately 4,000 patients will be enrolled from around 230 clinical sites, with an anticipated mean follow-up of 36months until 248 adjudicated primary outcome events have occurred. Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with subclinical AF and additional risk factors.

      PubDate: 2017-05-14T14:19:04Z
      DOI: 10.1016/j.ahj.2017.04.008
      Issue No: Vol. 189 (2017)
  • Cardiovascular events and hospital resource utilization pre– and
    • Authors: Sreekanth Vemulapalli; Steven J. Lippmann; Mitchell Krucoff; Adrian F. Hernandez; Lesley H. Curtis; Elyse Foster; Atif Qasim; Andrew Wang; Donald D. Glower; Ted Feldman; Bradley G. Hammill
      Pages: 146 - 157
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Sreekanth Vemulapalli, Steven J. Lippmann, Mitchell Krucoff, Adrian F. Hernandez, Lesley H. Curtis, Elyse Foster, Atif Qasim, Andrew Wang, Donald D. Glower, Ted Feldman, Bradley G. Hammill
      MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied. Methods Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 2010 US dollars, were calculated, and event rate ratios and cost ratios were estimated with multivariable modeling. Results Among 403 linked patients, the mean age was 80 years, 60% were male, mean baseline left ventricular ejection fraction was 49.6%, 83.3% were New York Heart Association class III/IV, 78.2% were MR grade 3+/4+, and 63.3% had functional MR. All-cause hospitalization decreased from 1,854 to 1,435/1,000 person-years (P <.001). HF hospitalization decreased following MitraClip (749 vs 332/1000 person-years, P <.001), but bleeding increased (199 vs 298/1000 person-years, P <.001). Changes in stroke and myocardial infarction were not statistically significant. Overall mean Medicare costs per patient were similar pre- and post-MitraClip, although there was a significant decrease in mean costs among those that survived a full year after MitraClip ($18,131 [SD $25,130] vs $11,679 [SD $22,486], P =.02). Conclusions MitraClip was associated with a reduced rate of all-cause and HF hospitalizations and an increased rate of bleeding hospitalizations. One-year Medicare costs were reduced in those who survived a full year after the MitraClip procedure. Payors and providers seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year.

      PubDate: 2017-05-14T14:19:04Z
      DOI: 10.1016/j.ahj.2017.04.012
      Issue No: Vol. 189 (2017)
  • High-risk echocardiographic features predict mortality in pulmonary
           arterial hypertension
    • Authors: Christopher Austin; Charles Burger; Garvan Kane; Robert Safford; Joseph Blackshear; Ryan Ung; Jordan Ray; Ali Alsaad; Khadija Alassas; Brian Shapiro
      Pages: 167 - 176
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Christopher Austin, Charles Burger, Garvan Kane, Robert Safford, Joseph Blackshear, Ryan Ung, Jordan Ray, Ali Alsaad, Khadija Alassas, Brian Shapiro
      Aims Echocardiography is the most common imaging modality for assessment of the right ventricle in patients with pulmonary arterial hypertension (PAH). Echocardiographic parameters were identified as independent risk factors for mortality in the Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) and other PAH cohorts. We sought to identify readily obtained echocardiographic features associated with PAH survival. Methods and results Retrospective analysis of 175 patients with Group 1 was performed. Baseline clinical and laboratory assessment including REVEAL risk criteria were obtained and standard 2-Dimensional and Doppler echocardiography performed at baseline was reviewed. Univariate and multivariate analyses of echocardiographic parameters were performed. Estimated right atrial pressure> 15 mmHg (HR 2.39, P = .02), tricuspid regurgitation ≥ moderate (HR 2.16, P = .04), and presence of pericardial effusion (HR 1.8, P = .05) were identified as independent, high-risk echocardiographic features in PAH. A validation cohort of 677 patients was identified and Kaplan–Meier survival analysis was performed in both cohorts. High-risk echocardiographic features stratified survival curves of both cohorts (P < .01 for all). The presence of 3 high-risk echocardiographic features greatly increased risk of 1-year (RR 4.86) and 3-year (RR 3.35) mortality (P < .05 for both). Conclusion Estimated right atrial pressure> 15, tricuspid regurgitation ≥ moderate, and presence of pericardial effusion are high-risk echocardiographic features in PAH. When seen in combination, these features greatly increase risk of mortality in PAH and may lead to more timely enhanced therapy for patients identified as having an increased risk for death.

      PubDate: 2017-05-14T14:19:04Z
      DOI: 10.1016/j.ahj.2017.04.013
      Issue No: Vol. 189 (2017)
  • Change the management of patients with heart failure: Rationale and design
           of the CHAMP-HF registry
    • Authors: Adam D. DeVore; Laine Thomas; Nancy M. Albert; Javed Butler; Adrian F. Hernandez; J. Herbert Patterson; John A. Spertus; Fredonia B. Williams; Stuart J. Turner; Wing W. Chan; Carol I. Duffy; Kevin McCague; Xiaojuan Mi; Gregg C. Fonarow
      Pages: 177 - 183
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Adam D. DeVore, Laine Thomas, Nancy M. Albert, Javed Butler, Adrian F. Hernandez, J. Herbert Patterson, John A. Spertus, Fredonia B. Williams, Stuart J. Turner, Wing W. Chan, Carol I. Duffy, Kevin McCague, Xiaojuan Mi, Gregg C. Fonarow
      Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients.

      PubDate: 2017-05-14T14:19:04Z
      DOI: 10.1016/j.ahj.2017.04.010
      Issue No: Vol. 189 (2017)
  • One-year mortality outcomes and hospital readmissions of patients admitted
           with acute heart failure: Data from the Trivandrum Heart Failure Registry
           in Kerala, India
    • Authors: Sivadasanpillai Harikrishnan; Ganapathi Sanjay; Anubha Agarwal; N. Pratap Kumar; K. Krishna Kumar; Charantharayil Gopalan Bahuleyan; Govindan Vijayaraghavan; Sunitha Viswanathan; Madhu Sreedharan; R. Biju; N. Rajalekshmi; Tiny Nair; Krishnan Suresh; Panniyammakal Jeemon
      Pages: 193 - 199
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Sivadasanpillai Harikrishnan, Ganapathi Sanjay, Anubha Agarwal, N. Pratap Kumar, K. Krishna Kumar, Charantharayil Gopalan Bahuleyan, Govindan Vijayaraghavan, Sunitha Viswanathan, Madhu Sreedharan, R. Biju, N. Rajalekshmi, Tiny Nair, Krishnan Suresh, Panniyammakal Jeemon
      Background There are sparse data on outcomes of patients with heart failure (HF) from India. The objective was to evaluate hospital readmissions and 1-year mortality outcomes of patients with HF in Kerala, India. Methods We followed 1,205 patients enrolled in the Trivandrum Heart Failure Registry for 1 year. A trained research nurse contacted each participant every 3 months using a structured questionnaire which included hospital readmission and mortality information. Results The mean (SD) age was 61.2 (13.7) years, and 31% were women. One out of 4 (26%) participants had HF with preserved ejection fraction. Only 25% of patients with HF with reduced ejection fraction received guideline-directed medical therapy at discharge. Cumulative all-cause mortality at 1 year was 30.8% (n = 371), but the greatest risk of mortality was in the first 3 months (18.1%). Most deaths (61%) occurred in patients younger than 70 years. One out of every 3 (30.2%) patients was readmitted at least once over 1 year. The hospital readmission rates were similar between HF with preserved ejection fraction and HF with reduced ejection fraction patients. New York Heart Association functional class IV status and lack of guideline-directed medical treatment after index hospitalization were associated with increased likelihood of readmission. Similarly, older age, lower education status, nonischemic etiology, history of stroke, higher serum creatinine, lack of adherence to guideline-directed medical therapy, and hospital readmissions were associated with increased 1-year mortality. Conclusions In the Trivandrum Heart Failure Registry, 1 of 3 HF patients died within 1 year of follow-up during their productive life years. Suboptimal adherence to guideline-directed treatment is associated with increased propensity of readmission and death. Quality improvement programs aiming to improve adherence to guideline-based therapy and reducing readmission may result in significant survival benefits in the relatively younger cohort of HF patients in India.
      Graphical abstract image

      PubDate: 2017-05-29T14:44:30Z
      DOI: 10.1016/j.ahj.2017.03.019
      Issue No: Vol. 189 (2017)
  • The economics of PCSK-9 inhibitors
    • Authors: Kevin A. Schulman; Shelby D. Reed
      Pages: 200 - 201
      Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189
      Author(s): Kevin A. Schulman, Shelby D. Reed

      PubDate: 2017-06-18T16:55:11Z
      DOI: 10.1016/j.ahj.2017.05.001
      Issue No: Vol. 189 (2017)
  • Mean arterial pressure of 65mmHg versus 85–100mmHg in comatose survivors
           after cardiac arrest: rationale and study design of the Neuroprotect
           post-cardiac arrest trial
    • Authors: K Ameloot; C De Deyne; B Ferdinande; M Dupont; PJ Palmers; T Petit; W Eertmans; C Moonen; A Belmans; R Lemmens; J Dens; S Janssens
      Abstract: Publication date: Available online 23 June 2017
      Source:American Heart Journal
      Author(s): K Ameloot, C De Deyne, B Ferdinande, M Dupont, PJ Palmers, T Petit, W Eertmans, C Moonen, A Belmans, R Lemmens, J Dens, S Janssens
      Background Post-Cardiac Arrest (CA) patients admitted to the intensive care unit (ICU) have a poor prognosis with estimated survival rates of around 30–50%. On admission, these patients have a large cerebral penumbra at risk for additional damage in case of suboptimal brain oxygenation during their stay in the ICU. The aim of the Neuroprotect post-CA trial is to investigate whether forcing mean arterial blood pressure (MAP) and mixed venous oxygen saturation (SVO2) in a specific range (MAP 85–100mmHg, SVO2 65–75%) with additional pharmacological support (goal directed hemodynamic optimization) may better salvage the penumbra, reduce cerebral ischemia and improve functional outcome when compared with current standard of care (MAP 65 mmHg). Design The Neuroprotect post-CA trial (NCT02541591) is a multicenter, randomized, parallel group, open label, assessor-blinded, monitored and investigator driven clinical trial. The trial will be conducted in 2 tertiary care hospitals in Belgium (UZ Leuven and ZOL-Genk). A total of 112 eligible patients will be randomly assigned in a 1:1 ratio to goal directed hemodynamic optimization or standard care strategy by an interactive voice response system. Patients will be stratified according to the presence of an initial shockable rhythm. Adult patients (≥ 18years) resuscitated from out-of-hospital CA of a presumed cardiac cause who are unconscious upon hospital admission are eligible for inclusion. Patients can be included irrespective of their presenting heart rhythm, but need to have a sustained return of spontaneous circulation. Trial interventions will take 36hours starting from ICU admission. The primary outcome is the extent of cerebral ischemia as quantified by the apparent diffusion coefficient (ADC) on diffusion weighted MRI (DW-MRI) to be performed at day 4–5 post-CA. Secondary outcomes include surrogate biomarkers of brain injury (neuron specific enolase) at day 1–5, neuropsychological and functional testing at hospital discharge, a SF-36 health questionnaire at 180days and outcome as assessed with cerebral performance category scores at ICU discharge and at 180days. Conclusions The Neuroprotect post-CA trial will investigate whether a more aggressive hemodynamic strategy to obtain a MAP 85–100mmHg and SVO2 65–75% reduces brain ischemia and improves outcome when compared with standard treatment (MAP 65 mmHg) in comatose post-CA survivors.

      PubDate: 2017-06-23T17:07:08Z
      DOI: 10.1016/j.ahj.2017.06.010
  • Soluble Endothelial Cell-Selective Adhesion Molecule and Incident
           Cardiovascular Events in a Multi-Ethnic Population
    • Authors: Hao-Yu Ren; Amit Khera; James A. de Lemos; Colby R. Ayers; Anand Rohatgi
      Abstract: Publication date: Available online 23 June 2017
      Source:American Heart Journal
      Author(s): Hao-Yu Ren, Amit Khera, James A. de Lemos, Colby R. Ayers, Anand Rohatgi
      Background Cell adhesion molecules are key regulators of atherosclerotic plaque development, but circulating levels of soluble fragments, such as intercellular adhesion molecule (sICAM-1) and vascular cell adhesion molecule (sVCAM-1), have yielded conflicting associations with atherosclerotic cardiovascular disease (ASCVD). Endothelial cell-selective adhesion molecule (ESAM) is expressed exclusively in platelets and endothelial cells, and soluble ESAM (sESAM) levels have been associated with prevalent subclinical atherosclerosis. We therefore hypothesized that sESAM would be associated with incident ASCVD. Methods sESAM, sICAM-1, and sVCAM-1 were measured in 2,442 participants without CVD in the Dallas Heart Study, a probability-based population sample age 30–65 enrolled between 2000–2002. ASCVD was defined as first myocardial infarction, stroke, coronary revascularization, or CV death. A total of 162 ASCVD events were analyzed over 10.4 years. Results Increasing sESAM was associated with ASCVD, independent of risk factors (HR Q4 vs. Q1: 2.7, 95% CI 1.6–4.6). Serial adjustment for renal function, sICAM-1, VCAM-1, and prevalent coronary calcium did not attenuate these associations. Continuous ESAM demonstrated similar findings (HR 1.31 95% CI 1.2–1.4). Addition of sESAM to traditional risk factors improved discrimination and reclassification (delta c-index: p=0.009; IDI p=0.001; NRI = 0.42, 95% CI 0.15–0.68). Neither sICAM-1 nor sVCAM-1 was independently associated with ASCVD. Conclusions sESAM but not sICAM-1 or sVCAM-1 levels are associated with incident ASCVD. Further studies are warranted to investigate the role of sESAM in ASCVD.

      PubDate: 2017-06-23T17:07:08Z
      DOI: 10.1016/j.ahj.2017.06.008
  • Overview of the 2017 US Food and Drug Administration Circulatory System
           Devices Panel Meeting on the Sentinel Cerebral Protection System
    • Authors: Toby Rogers; M. Chadi Alraies; Rebecca Torguson; Ron Waksman
      Abstract: Publication date: Available online 23 June 2017
      Source:American Heart Journal
      Author(s): Toby Rogers, M. Chadi Alraies, Rebecca Torguson, Ron Waksman

      PubDate: 2017-06-23T17:07:08Z
      DOI: 10.1016/j.ahj.2017.06.007
  • Pulmonary Hemodynamics in Heart Failure Patients with Reduced or Preserved
           Ejection Fraction and Pulmonary Hypertension: Similarities and Disparities
    • Authors: Yochai Adir; Marco Guazzi; Amir Offer; Pier Luigi Temporelli; Antonia Cannito; Stefano Ghio
      Abstract: Publication date: Available online 21 June 2017
      Source:American Heart Journal
      Author(s): Yochai Adir, Marco Guazzi, Amir Offer, Pier Luigi Temporelli, Antonia Cannito, Stefano Ghio
      Objective The current understanding of pulmonary hypertension (PH) due to left heart diseases does not distinguish heart failure (HF) with reduced ejection fraction (HFrEF) from HF and preserved ejection fraction (HFpEF), in terms of pulmonary hemodynamics. The value of pulmonary vascular compliance (PCa) and diastolic pulmonary gradient (DPG) as predictors of survival in either HF syndrome is controversial. The aims of our study were to compare the pulmonary hemodynamics in the two HF phenotypes, given similar values of pulmonary artery wedge pressure (PAWP), and to evaluate the impact of PCa and DPG on survival. Methods We retrospectively reviewed the charts of 168 PH-HFrEF and 86 PH-HFpEF patients. The independent association of PCa and DPG with prognosis was assessed by means of a Cox proportional hazard model. All cause survival was analyzed over an average follow-up period of 50months. Results PH-HFpEF patients had a significantly higher DPG than PH-HFrEF patients (6.1±7.1 vs. 1.8±4.5mmHg, adjusted P =.025). PCa was similar in PH-HFpEF and PH-HFrEF. PCa was a significant predictor of survival, according to previously described preset cutoffs (2.15mL/mmHg in HFrEF and 1.1mL/mmHg in HFpEF) and based on a continuous scale; whereas DPG had no impact on survival in both patients groups. Conclusion Our findings suggest that for similar levels of PAWP, pulmonary circulation may be stiffer in patients with HFpEF-PH than patients with HFrEF-PH, leading to higher DPGs. Nonetheless, PCa rather than DPG emerged as the stronger predictor of survival in both left-sided PH phenotypes.

      PubDate: 2017-06-23T17:07:08Z
      DOI: 10.1016/j.ahj.2017.06.006
  • Information for Readers
    • Abstract: Publication date: July 2017
      Source:American Heart Journal, Volume 189

      PubDate: 2017-06-18T16:55:11Z
  • The Troponin Decision-Point Dilemma: The 99th Percentile Solution “Do
           the best you can [with cardiac troponin] until you know better. Then when
           you know better, do better.” Maya Angelou, Poet, Dancer, Producer,
           Playwright, Director, Author
    • Authors: Robert H. Christenson; Christopher R. deFilippi
      Abstract: Publication date: Available online 16 June 2017
      Source:American Heart Journal
      Author(s): Robert H. Christenson, Christopher R. deFilippi

      PubDate: 2017-06-18T16:55:11Z
      DOI: 10.1016/j.ahj.2017.06.004
  • New York Heart Association Class and the Survival Benefit from Primary
           Prevention Implantable Cardioverter Defibrillators: A Pooled Analysis of 4
           Randomized Controlled Trials
    • Authors: Daniel J. Friedman; Sana M. Al-Khatib; Emily P. Zeitler; JooYoon Han; Gust H. Bardy; Jeanne E. Poole; J. Thomas Bigger; Alfred E. Buxton; Arthur J. Moss; Kerry L. Lee; Richard Steinman; Paul Dorian; Riccardo Cappato; Alan H. Kadish; Peter J. Kudenchuk; Daniel B. Mark; Lurdes Y.T. Inoue; Gillian D. Sanders
      Abstract: Publication date: Available online 9 June 2017
      Source:American Heart Journal
      Author(s): Daniel J. Friedman, Sana M. Al-Khatib, Emily P. Zeitler, JooYoon Han, Gust H. Bardy, Jeanne E. Poole, J. Thomas Bigger, Alfred E. Buxton, Arthur J. Moss, Kerry L. Lee, Richard Steinman, Paul Dorian, Riccardo Cappato, Alan H. Kadish, Peter J. Kudenchuk, Daniel B. Mark, Lurdes Y.T. Inoue, Gillian D. Sanders
      Background Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure (HF) derive ICD benefit owing to the competing risk of non-sudden death. Methods We performed a patient level meta-analysis of New York Heart Association class (NYHA) class II/III HF patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian–Weibull survival regression models were employed to assess the impact of NYHA class on the relationship between ICD use and mortality. Results Of the 2763 patients who met study criteria, 68% (n=1867) were NYHA II and 52% (n=1435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality [HR 0.65, 95% posterior credibility interval (PCI) 0.40–0.99]. The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=0.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35–0.85) and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48–1.24) although this was not statistically significant. Conclusions Primary prevention ICDs reduce mortality in NYHA class II patients and trend towards reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.

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

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

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

      PubDate: 2017-05-19T14:29:24Z
      DOI: 10.1016/j.ahj.2017.05.004
  • Multicenter automatic defibrillator implantation trial - subcutaneous
           implantable cardioverter defibrillator (MADIT S-ICD): Design and clinical
    • Authors: Valentina Kutyifa; Christopher Beck; Mary W. Brown; David Cannom; James Daubert; Mark Estes; Henry Greenberg; Ilan Goldenberg; Stephen Hammes; David Huang; Helmut Klein; Reinoud Knops; Mikhail Kosiborod; Jeanne Poole; Claudio Schuger; Jagmeet P. Singh; Scott Solomon; David Wilber; Wojciech Zareba; Arthur J. Moss
      Abstract: Publication date: Available online 4 May 2017
      Source:American Heart Journal
      Author(s): Valentina Kutyifa, Christopher Beck, Mary W. Brown, David Cannom, James Daubert, Mark Estes, Henry Greenberg, Ilan Goldenberg, Stephen Hammes, David Huang, Helmut Klein, Reinoud Knops, Mikhail Kosiborod, Jeanne Poole, Claudio Schuger, Jagmeet P. Singh, Scott Solomon, David Wilber, Wojciech Zareba, Arthur J. Moss
      Patients with diabetes mellitus, prior myocardial infarction, older age and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the S-ICD with a good risk–benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post-MI diabetes patients with relatively preserved ejection fraction of 36–50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator (S-ICD).

      PubDate: 2017-05-04T12:08:37Z
      DOI: 10.1016/j.ahj.2017.04.014
  • Probing oral anticoagulation in patients with atrial high rate episodes.
           Rationale and design of the Non vitamin K antagonist Oral anticoagulants
           in patients with Atrial High rate episodes (NOAH – AFNET 6) trial
    • Authors: Paulus Kirchhof; Benjamin F Blank; Melanie Calvert; A John Camm; Gregory Chlouverakis; Hans-Christoph Diener; Andreas Goette; Andrea Huening; Gregory Y.H. Lip; Emmanuel Simantirakis; Panos Vardas
      Abstract: Publication date: Available online 3 May 2017
      Source:American Heart Journal
      Author(s): Paulus Kirchhof, Benjamin F Blank, Melanie Calvert, A John Camm, Gregory Chlouverakis, Hans-Christoph Diener, Andreas Goette, Andrea Huening, Gregory Y.H. Lip, Emmanuel Simantirakis, Panos Vardas
      Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation. Early detection of atrial fibrillation and subsequent initiation of oral anticoagulation help to prevent strokes in atrial fibrillation patients. Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes (AHRE), but the best antithrombotic therapy in patients with AHRE is not known. Rationale Stroke risk is higher in pacemaker patients with AHRE than in those without, but the available data also show that stroke risk in patients with AHRE is lower than in patients with atrial fibrillation. Furthermore, only a minority of patients with AHRE will develop AF, many strokes occur without a temporal relation to AHRE, and AHRE can reflect other arrhythmias than AF or artefacts. An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed. Design The NOAH – AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared to aspirin or no antithrombotic therapy based on evidence-based indications. The primary safety outcome will be major bleeding. NOAH – AFNET 6 will randomise 3400 patients with AHRE, but without documented AF, aged 65 or older with at least one other stroke risk factor, to oral anticoagulation therapy (edoxaban) or no anticoagulation. All patients will be followed until the end of this investigator-driven, prospective, parallel-group, randomised, event-driven, double-blind, multi-centre phase IIIb trial. Patients will be censored when they develop atrial fibrillation and offered open label anticoagulation. The sponsor is the Atrial Fibrillation NETwork (AFNET). The trial is supported by the DZHK (German Centre for Cardiovascular Research), by the BMBF (German Ministry of Education and Research) and by Daiichi Sankyo Europe. Conclusion NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices.
      Graphical abstract image

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