Subjects -> MEDICAL SCIENCES (Total: 8359 journals)
    - ALLERGOLOGY AND IMMUNOLOGY (210 journals)
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CARDIOVASCULAR DISEASES (329 journals)                  1 2 | Last

Showing 1 - 200 of 329 Journals sorted alphabetically
Acta Angiologica     Open Access   (Followers: 5)
Acta Cardiologica     Hybrid Journal   (Followers: 2)
Acute Cardiac Care     Hybrid Journal   (Followers: 7)
Adipositas - Ursachen, Folgeerkrankungen, Therapie     Hybrid Journal  
AJP Heart and Circulatory Physiology     Hybrid Journal   (Followers: 12)
Aktuelle Kardiologie     Hybrid Journal   (Followers: 1)
American Heart Journal     Hybrid Journal   (Followers: 58)
American Journal of Cardiology     Hybrid Journal   (Followers: 67)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 17)
American Journal of Hypertension     Hybrid Journal   (Followers: 28)
Anales de Cirugia Vascular     Full-text available via subscription   (Followers: 1)
Anatolian Journal of Cardiology     Open Access   (Followers: 6)
Angiología     Full-text available via subscription  
Angiologia e Cirurgia Vascular     Open Access   (Followers: 1)
Angiology     Hybrid Journal   (Followers: 3)
Annales de Cardiologie et d'Angéiologie     Full-text available via subscription   (Followers: 1)
Annals of Noninvasive Electrocardiology     Hybrid Journal   (Followers: 1)
Annals of Pediatric Cardiology     Open Access   (Followers: 12)
AORTA     Open Access  
Archives of Cardiovascular Diseases     Full-text available via subscription   (Followers: 5)
Archives of Cardiovascular Diseases Supplements     Full-text available via subscription   (Followers: 3)
Archives of Cardiovascular Imaging     Open Access   (Followers: 2)
Archivos de cardiología de México     Open Access   (Followers: 1)
Argentine Journal of Cardiology (English edition)     Open Access   (Followers: 2)
Arquivos Brasileiros de Cardiologia     Open Access   (Followers: 1)
Arteriosclerosis, Thrombosis and Vascular Biology     Full-text available via subscription   (Followers: 32)
Artery Research     Hybrid Journal   (Followers: 4)
ARYA Atherosclerosis     Open Access  
ASAIO Journal     Hybrid Journal   (Followers: 3)
ASEAN Heart Journal     Open Access   (Followers: 2)
Asian Cardiovascular and Thoracic Annals     Hybrid Journal   (Followers: 2)
Aswan Heart Centre Science & Practice Services     Open Access   (Followers: 1)
Atherosclerosis : X     Open Access  
Bangladesh Heart Journal     Open Access   (Followers: 3)
Basic Research in Cardiology     Hybrid Journal   (Followers: 10)
BMC Cardiovascular Disorders     Open Access   (Followers: 22)
Brain Circulation     Open Access   (Followers: 1)
British Journal of Cardiology     Full-text available via subscription   (Followers: 16)
Canadian Journal of Cardiology     Hybrid Journal   (Followers: 18)
Cardiac Cath Lab Director     Full-text available via subscription  
Cardiac Electrophysiology Review     Hybrid Journal   (Followers: 2)
Cardiocore     Full-text available via subscription   (Followers: 1)
Cardiogenetics     Open Access   (Followers: 3)
Cardiology     Full-text available via subscription   (Followers: 20)
Cardiology and Angiology: An International Journal     Open Access  
Cardiology and Therapy     Open Access   (Followers: 12)
Cardiology Clinics     Full-text available via subscription   (Followers: 14)
Cardiology in Review     Hybrid Journal   (Followers: 8)
Cardiology in the Young     Hybrid Journal   (Followers: 34)
Cardiology Journal     Open Access   (Followers: 6)
Cardiology Plus     Open Access   (Followers: 1)
Cardiology Research     Open Access   (Followers: 15)
Cardiology Research and Practice     Open Access   (Followers: 10)
Cardiopulmonary Physical Therapy Journal     Hybrid Journal   (Followers: 7)
Cardiorenal Medicine     Full-text available via subscription   (Followers: 1)
Cardiothoracic Surgeon     Open Access  
CardioVasc     Full-text available via subscription   (Followers: 1)
Cardiovascular & Haematological Disorders - Drug Targets     Hybrid Journal   (Followers: 1)
Cardiovascular & Hematological Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 2)
CardioVascular and Interventional Radiology     Hybrid Journal   (Followers: 15)
Cardiovascular and Thoracic Open     Open Access  
Cardiovascular Diabetology     Open Access   (Followers: 10)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 14)
Cardiovascular Endocrinology & Metabolism     Hybrid Journal   (Followers: 1)
Cardiovascular Engineering     Hybrid Journal   (Followers: 1)
Cardiovascular Engineering and Technology     Hybrid Journal   (Followers: 1)
Cardiovascular Intervention and Therapeutics     Hybrid Journal   (Followers: 5)
Cardiovascular Journal     Open Access   (Followers: 6)
Cardiovascular Journal of Africa     Full-text available via subscription   (Followers: 5)
Cardiovascular Journal of South Africa     Full-text available via subscription   (Followers: 1)
Cardiovascular Medicine in General Practice     Full-text available via subscription   (Followers: 7)
Cardiovascular Pathology     Hybrid Journal   (Followers: 4)
Cardiovascular Regenerative Medicine     Open Access  
Cardiovascular Research     Hybrid Journal   (Followers: 15)
Cardiovascular Revascularization Medicine     Hybrid Journal   (Followers: 1)
Cardiovascular System     Open Access  
Cardiovascular Therapeutics     Open Access   (Followers: 1)
Cardiovascular Toxicology     Hybrid Journal   (Followers: 6)
Cardiovascular Ultrasound     Open Access   (Followers: 5)
Case Reports in Cardiology     Open Access   (Followers: 7)
Catheterization and Cardiovascular Interventions     Hybrid Journal   (Followers: 3)
Cerebrovascular Diseases     Full-text available via subscription   (Followers: 3)
Cerebrovascular Diseases Extra     Open Access  
Chest     Full-text available via subscription   (Followers: 100)
Choroby Serca i Naczyń     Open Access   (Followers: 1)
Circulation     Hybrid Journal   (Followers: 247)
Circulation : Cardiovascular Imaging     Hybrid Journal   (Followers: 15)
Circulation : Cardiovascular Interventions     Hybrid Journal   (Followers: 17)
Circulation : Cardiovascular Quality and Outcomes     Hybrid Journal   (Followers: 11)
Circulation : Genomic and Precision Medicine     Hybrid Journal   (Followers: 15)
Circulation : Heart Failure     Hybrid Journal   (Followers: 26)
Circulation Research     Hybrid Journal   (Followers: 36)
Cirugía Cardiovascular     Open Access  
Clínica e Investigación en Arteriosclerosis     Full-text available via subscription  
Clínica e Investigación en arteriosclerosis (English Edition)     Hybrid Journal  
Clinical and Experimental Hypertension     Hybrid Journal   (Followers: 3)
Clinical Cardiology     Hybrid Journal   (Followers: 11)
Clinical Hypertension     Open Access   (Followers: 5)
Clinical Medicine Insights : Cardiology     Open Access   (Followers: 6)
Clinical Research in Cardiology     Hybrid Journal   (Followers: 6)
Clinical Research in Cardiology Supplements     Hybrid Journal  
Clinical Trials and Regulatory Science in Cardiology     Open Access   (Followers: 4)
Congenital Heart Disease     Hybrid Journal   (Followers: 6)
Congestive Heart Failure     Hybrid Journal   (Followers: 4)
Cor et Vasa     Full-text available via subscription   (Followers: 1)
Coronary Artery Disease     Hybrid Journal   (Followers: 2)
CorSalud     Open Access  
Critical Pathways in Cardiology     Hybrid Journal   (Followers: 4)
Current Cardiology Reports     Hybrid Journal   (Followers: 7)
Current Cardiology Reviews     Hybrid Journal   (Followers: 4)
Current Cardiovascular Imaging Reports     Hybrid Journal   (Followers: 1)
Current Cardiovascular Risk Reports     Hybrid Journal  
Current Heart Failure Reports     Hybrid Journal   (Followers: 5)
Current Hypertension Reports     Hybrid Journal   (Followers: 6)
Current Hypertension Reviews     Hybrid Journal   (Followers: 6)
Current Opinion in Cardiology     Hybrid Journal   (Followers: 14)
Current Problems in Cardiology     Hybrid Journal   (Followers: 3)
Current Research : Cardiology     Full-text available via subscription   (Followers: 1)
Current Treatment Options in Cardiovascular Medicine     Hybrid Journal   (Followers: 1)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 5)
CVIR Endovascular     Open Access   (Followers: 1)
Der Kardiologe     Hybrid Journal   (Followers: 2)
Echo Research and Practice     Open Access   (Followers: 2)
Echocardiography     Hybrid Journal   (Followers: 4)
Egyptian Heart Journal     Open Access   (Followers: 2)
Egyptian Journal of Cardiothoracic Anesthesia     Open Access  
ESC Heart Failure     Open Access   (Followers: 4)
European Heart Journal     Hybrid Journal   (Followers: 67)
European Heart Journal - Cardiovascular Imaging     Hybrid Journal   (Followers: 10)
European Heart Journal - Cardiovascular Pharmacotherapy     Full-text available via subscription   (Followers: 3)
European Heart Journal - Quality of Care and Clinical Outcomes     Hybrid Journal  
European Heart Journal : Acute Cardiovascular Care     Hybrid Journal   (Followers: 1)
European Heart Journal : Case Reports     Open Access   (Followers: 1)
European Heart Journal Supplements     Hybrid Journal   (Followers: 8)
European Journal of Cardio-Thoracic Surgery     Hybrid Journal   (Followers: 9)
European Journal of Cardio-Thoracic Surgery Supplements     Full-text available via subscription   (Followers: 2)
European Journal of Cardiovascular Nursing     Hybrid Journal   (Followers: 5)
European Journal of Heart Failure     Hybrid Journal   (Followers: 14)
European Journal of Preventive Cardiology.     Hybrid Journal   (Followers: 6)
European Stroke Organisation     Hybrid Journal   (Followers: 3)
Experimental & Translational Stroke Medicine     Open Access   (Followers: 8)
Expert Review of Cardiovascular Therapy     Full-text available via subscription   (Followers: 3)
Folia Cardiologica     Open Access  
Forum Zaburzeń Metabolicznych     Hybrid Journal  
Frontiers in Cardiovascular Medicine     Open Access   (Followers: 1)
Future Cardiology     Hybrid Journal   (Followers: 6)
General Thoracic and Cardiovascular Surgery     Hybrid Journal   (Followers: 3)
Global Cardiology Science and Practice     Open Access   (Followers: 5)
Global Heart     Hybrid Journal   (Followers: 3)
Heart     Hybrid Journal   (Followers: 48)
Heart and Mind     Open Access  
Heart and Vessels     Hybrid Journal  
Heart Failure Clinics     Full-text available via subscription   (Followers: 2)
Heart Failure Reviews     Hybrid Journal   (Followers: 3)
Heart India     Open Access   (Followers: 2)
Heart International     Full-text available via subscription  
Heart Rhythm     Hybrid Journal   (Followers: 11)
Heart Views     Open Access   (Followers: 2)
HeartRhythm Case Reports     Open Access  
Hellenic Journal of Cardiology     Open Access   (Followers: 1)
Herz     Hybrid Journal   (Followers: 3)
High Blood Pressure & Cardiovascular Prevention     Full-text available via subscription   (Followers: 2)
Hypertension     Full-text available via subscription   (Followers: 23)
Hypertension in Pregnancy     Hybrid Journal   (Followers: 9)
Hypertension Research     Hybrid Journal   (Followers: 5)
Ibrahim Cardiac Medical Journal     Open Access  
IJC Heart & Vessels     Open Access   (Followers: 1)
IJC Heart & Vasculature     Open Access   (Followers: 1)
IJC Metabolic & Endocrine     Open Access   (Followers: 1)
Indian Heart Journal     Open Access   (Followers: 5)
Indian Journal of Cardiovascular Disease in Women WINCARS     Open Access  
Indian Journal of Thoracic and Cardiovascular Surgery     Hybrid Journal  
Indian Pacing and Electrophysiology Journal     Open Access   (Followers: 1)
Innovations : Technology and Techniques in Cardiothoracic and Vascular Surgery     Hybrid Journal   (Followers: 1)
Insuficiencia Cardíaca     Open Access  
Interactive CardioVascular and Thoracic Surgery     Hybrid Journal   (Followers: 7)
International Cardiovascular Forum Journal     Open Access  
International Journal of Angiology     Hybrid Journal   (Followers: 2)
International Journal of Cardiology     Hybrid Journal   (Followers: 18)
International Journal of Cardiovascular and Cerebrovascular Disease     Open Access   (Followers: 2)
International Journal of Cardiovascular Imaging     Hybrid Journal   (Followers: 2)
International Journal of Cardiovascular Research     Hybrid Journal   (Followers: 6)
International Journal of Heart Rhythm     Open Access  
International Journal of Hypertension     Open Access   (Followers: 8)
International Journal of Hyperthermia     Open Access  
International Journal of Stroke     Hybrid Journal   (Followers: 30)
International Journal of the Cardiovascular Academy     Open Access  
Interventional Cardiology Clinics     Full-text available via subscription   (Followers: 2)
Interventional Cardiology Review     Full-text available via subscription  
JACC : Basic to Translational Science     Open Access   (Followers: 5)
JACC : Cardiovascular Imaging     Hybrid Journal   (Followers: 18)
JACC : Cardiovascular Interventions     Hybrid Journal   (Followers: 17)
JACC : Heart Failure     Full-text available via subscription   (Followers: 14)
JAMA Cardiology     Hybrid Journal   (Followers: 28)
JMIR Cardio     Open Access  
Jornal Vascular Brasileiro     Open Access  
Journal of Clinical & Experimental Cardiology     Open Access   (Followers: 5)
Journal of Arrhythmia     Open Access  
Journal of Cardiac Critical Care TSS     Open Access   (Followers: 1)
Journal of Cardiac Failure     Hybrid Journal   (Followers: 1)

        1 2 | Last

Similar Journals
Journal Cover
American Heart Journal
Journal Prestige (SJR): 3.267
Citation Impact (citeScore): 4
Number of Followers: 58  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
Published by Elsevier Homepage  [3161 journals]
  • Rationale and Design for a Multicenter, randomized, double-blind,
           placebo-controlled, phase 2 study evaluating the safety and efficacy of
           the soluble Guanylate Cyclase stimulator Praliciguat over 12 weeks in
           patients with heart failure with preserved ejection fraction (CAPACITY
           HFpEF)
    • Abstract: Publication date: Available online 21 January 2020Source: American Heart JournalAuthor(s): James E. Udelson, Gregory D. Lewis, Sanjiv J. Shah, Michael R. Zile, Margaret M. Redfield, John Burnett, Robert S. Mittleman, Albert T. Profy, Jelena P. Seferovic, David Reasner, Marvin A. KonstamBackgroundHeart failure with preserved ejection fraction (HFpEF), is a significant cause of morbidity and mortality worldwide. Exercise intolerance is the main symptom of HFpEF and is associated with a poor quality of life and increased mortality. Currently, there are no approved medications for the treatment of HFpEF. Praliciguat (IW-1973), a novel sGC stimulator that may help restore deficient NO-sGC-cGMP signaling, is being investigated for the treatment of patients with HFpEF.MethodsCAPACITY HFpEF is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the safety and efficacy of praliciguat over 12 weeks in approximately 184 patients with HFpEF. Eligible patients must have evidence supporting clinical HFpEF and at least two of the following four conditions associated with NO deficiency: diabetes/prediabetes, hypertension, obesity, age> 70 years. The primary efficacy endpoint is the change from baseline in peak VO2 by cardiopulmonary exercise test (CPET). Secondary endpoints include the change from baseline in 6-minute walk test distance and the change in ventilatory efficiency on CPET, as well as number of CPET responders. Other exploratory endpoints include changes in echocardiographic parameters, New York Heart Association functional classification, cardiac events, blood and urine biomarkers pathophysiologically relevant to heart failure, and patient-reported outcomes including Kansas City Cardiomyopathy Questionnaire.ConclusionThe CAPACITY HFpEF trial will provide data on short-term safety and efficacy of praliciguat on peak exercise capacity, as well as multiple secondary endpoints of submaximal functional capacity, patient-reported outcomes, and biomarkers.
       
  • Contraceptive methods of privately-insured U.S. women with congenital
           heart defects
    • Abstract: Publication date: Available online 21 January 2020Source: American Heart JournalAuthor(s): Kayla N. Anderson, Naomi K. Tepper, Karrie Downing, Elizabeth C. Ailes, Ginnie Abarbanell, Sherry L. FarrAbstractBackgroundThe American Heart Association recommends women with congenital heart defects (CHD) receive contraceptive counseling early in their reproductive years, but little is known about contraceptive method use among women with CHD. We describe recent female sterilization and reversible prescription contraceptive method use by presence of CHD and CHD severity in 2014.MethodsUsing IBM MarketScan Commercial Databases, we included women aged 15–44 years with prescription drug coverage in 2014 who were enrolled ≥11 months annually in employer-sponsored health plans between 2011–2014. CHD, CHD severity, contraceptive methods, and obstetric-gynecology and cardiology provider encounters were identified using billing codes. We used log-binomial regression to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) to compare contraceptive method use overall and by effectiveness tier by CHD presence and, for women with CHD, severity.ResultsRecent sterilization or current reversible prescription contraceptive method use varied slightly among women with (39.2%) and without (37.3%) CHD, aPR = 1.04, 95% CI [1.01–1.07]. Women with CHD were more likely to use any Tier I method (12.9%) than women without CHD (9.3%), aPR = 1.41, 95% CI [1.33–1.50]. Women with severe, compared to non-severe, CHD were less likely to use any method, aPR = 0.85, 95% CI [0.78–0.92], or Tier I method, aPR = 0.84, 95% CI [0.70–0.99]. Approximately 60% of women with obstetric-gynecology and
       
  • Treatment strategies and subsequent changes in the patient-reported
           quality-of-life among elderly patients with atrial fibrillation
    • Abstract: Publication date: Available online 21 January 2020Source: American Heart JournalAuthor(s): Kotaro Miura, Nobuhiro Ikemura, Takehiro Kimura, Yoshinori Katsumata, Ikuko Ueda, Kojiro Tanimoto, Takahiro Ohki, Daisuke Shinmura, Koji Negishi, Keiichi Fukuda, Seiji Takatsuki, Shun KohsakaAbstractBackgroundRhythm-control strategy, including catheter ablation (CA) application, constitutes an integral part of atrial fibrillation (AF) management. However, elderly patients are underrepresented in clinical trials, and reports on patient-reported outcome of various rhythm-control treatments remain limited. Therefore, we aimed to investigate the application of a rhythm-control strategy for elderly patients with AF.MethodsUsing a prospective, multicenter Japanese registry, we analyzed 733 patients with AF aged ≥70 years who completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire at baseline and 1-year visit. Improvement in patient-reported quality-of-life (QOL) was assessed according to their initial treatment strategy.ResultsA total of 321 patients (43.8%) were managed with rhythm-control strategy, of which 125 (17.1%) received treatment with antiarrhythmic drugs (AADs) alone and 196 (26.7%) underwent CA. Compared with the rate-control group, the rhythm-control group was younger and less likely to have comorbid conditions but had lower baseline AFEQT-overall summary (OS) scores (71.8 [standard deviation 20.3] vs. 80.0 [standard deviation 16.1]; P 
       
  • EMERGEncy versus delayed coronary angiogram in survivors of
           out-of-hospital cardiac arrest with no obvious non-cardiac cause of
           arrest: Design of the EMERGE trial
    • Abstract: Publication date: Available online 17 January 2020Source: American Heart JournalAuthor(s): Caroline Hauw-Berlemont, Lionel Lamhaut, Jean-Luc Diehl, Christophe Andreotti, Olivier Varenne, Pierre Leroux, Jean-Baptiste Lascarrou, Patrice Guerin, Thomas Loeb, Eric Roupie, Cédric Daubin, Farzin Beygui, Sophie Glippa, Juliette Djadi-Prat, Gilles Chatellier, Alain Cariou, Christian Spaulding, for the EMERGE investigatorsBackgroundIn adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation.HypothesisPerforming an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest.DesignThe EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay.SummaryThe EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.
       
  • Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of
           cardiovascular events with dalcetrapib
    • Abstract: Publication date: Available online 17 January 2020Source: American Heart JournalAuthor(s): Jean-Claude Tardif, Marie-Pierre Dubé, Marc A. Pfeffer, David D. Waters, Wolfgang Koenig, Aldo P. Maggioni, John J.V. McMurray, Vincent Mooser, Harvey D. White, Therese Heinonen, Donald M. Black, Marie-Claude Guertin, the dal-GenE Investigators.AbstractThe objectives of precision medicine are to better match patient characteristics with the therapeutic intervention to optimize the chances of beneficial actions while reducing the exposure to unneeded adverse drug experiences. In a retrospective genome-wide association study of the overall neutral placebo-controlled dal-Outcomes trial, the effect of the cholesteryl ester transfer protein (CETP) modulator dalcetrapib on the composite of cardiovascular death, myocardial infarction or stroke was found to be influenced by a polymorphism in the adenylate cyclase type 9 (ADCY9) gene. Whereas patients with the AA genotype at position rs1967309 experienced fewer cardiovascular events with dalcetrapib, those with the GG genotype had an increased rate and the heterozygous AG genotype exhibited no difference from placebo. Measurements of cholesterol efflux and C-reactive protein (CRP) offered directionally supportive genotype-specific findings. In a separate, smaller, placebo-controlled trial, regression of ultrasonography-determined carotid intimal-medial thickness was only observed in dalcetrapib-treated patients with the AA genotype. Collectively, these observations led to the hypothesis that the cardiovascular effects of dalcetrapib may be pharmacogenetically determined, with a favorable benefit-risk ratio only for patients with this specific genotype. We describe below the design of dal-GenE, a precision medicine, placebo-controlled clinical outcome trial of dalcetrapib in patients with a recent acute myocardial infarction with the unique feature of selecting only those with the AA genotype at rs1967309 in the ADCY9 gene.
       
  • Incidence, underlying conditions, and outcomes of patients receiving acute
           renal replacement therapies in tertiary cardiac intensive care units: An
           analysis from the critical care cardiology trials network registry
    • Abstract: Publication date: Available online 15 January 2020Source: American Heart JournalAuthor(s): Sean van Diepen, Wayne Tymchak, Erin A. Bohula, Jeong-Gun Park, Lori B. Daniels, Nicholas Phreaner, Christopher F. Barnett, Benjamin B Kenigsberg, Andrew DeFilippis, Narayana Sarma Singam, Gregory W. Barsness, Jacob C. Jentzer, Bradley Ternus, David A. Morrow, Jason N. Katz, Critical Care Cardiology Trials Network InvestigatorsBackgroundThe prevalence of renal disease in cardiac intensive care units (CICUs) is increasing, but little is known about the utilization, concurrent therapies, and outcomes of patients requiring acute renal replacement therapy (RRT) in this specialized environment.MethodsIn the Critical Care Cardiology Trials Network, 16 centers submitted data on CICU admissions including acute RRT (defined as continuous renal replacement therapy and/or acute intermittent dialysis).ResultsAmong 2985 admissions, 178 (6.0%; interhospital range 1.0%–16.0%) received acute RRT. Patients receiving RRT, versus not, were more commonly admitted for cardiogenic shock (15.7% vs 4.2%, P 
       
  • Implementation of best practices – Developing and optimizing regional
           Systems of Stroke Care: Design and methodology
    • Abstract: Publication date: Available online 15 January 2020Source: American Heart JournalAuthor(s): Matthew E Ehrlich, Brad J Kolls, Mayme Roettig, Lisa Monk, Shreyansh Shah, Ying Xian, James G Jollis, Christopher B Granger, Carmelo GraffagninoAbstractThe AHA Guidelines recommend developing multi-tiered systems for the care of patients with acute stroke.1 An ideal stroke system of care should ensure that all patients receive the most efficient and timely care, regardless of how they first enter or access the medical care system. Coordination among the components of a stroke system is the most challenging but most essential aspect of any system of care.The Implementation of Best Practices For Acute Stroke Care – Developing and Optimizing Regional Systems of Stroke Care (IMPROVE Stroke Care) project, is designed to implement existing guidelines and systematically improve the acute stroke system of care in the Southeastern United States. Project participation includes 9 hub hospitals, approximately 80 spoke hospitals, numerous pre-hospital agencies (911, fire, and emergency medical services) and communities within the region. The goal of the IMPROVE Stroke program is to develop a regional integrated stroke care system that identifies, classifies, and treats acute ischemic stroke patients more rapidly and effectively with reperfusion therapy. The project will identify gaps and barriers to implementation of stroke systems of care, leverage existing resources within the regions, aid in designing strategies to improve care processes, bring regional representatives together to agree on and implement best practices, protocols, and plans based on guidelines, and establish methods to monitor quality of care. The impact of implementation of stroke systems of care on mortality and long-term functional outcomes will be measured.
       
  • Underweight is associated with inferior short and long-term outcomes after
           MitraClip implantation: Results from the German TRAnscatheter mitral valve
           interventions (TRAMI) registry
    • Abstract: Publication date: Available online 10 January 2020Source: American Heart JournalAuthor(s): D. Kalbacher, E. Tigges, P. Boekstegers, M. Puls, B. Plicht, H. Eggebrecht, G. Nickenig, R.S.v. Bardeleben, C.S. Zuern, J. Franke, H. Sievert, T. Ouarrak, J. Senges, E. LubosAbstractBackgroundUnderweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease.AimsThe current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy.Methods and ResultsFrom 08/2010 until 07/2013, 799 patients (age 75.3 ± 8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into four groups: BMI
       
  • Long-term clinical outcomes with use of an angiotensin-converting enzyme
           inhibitor early after heart transplantation
    • Abstract: Publication date: Available online 9 January 2020Source: American Heart JournalAuthor(s): Hiroyuki Arashi, Takuma Sato, Jon Kobashigawa, Helen Luikart, Yuhei Kobayashi, Kozo Okada, Seema Sinha, Yasuhiro Honda, Alan C. Yeung, Kiran Khush, William F. FearonAbstractBackgroundThe safety and efficacy of angiotensin converting enzyme inhibition (ACEI) after heart transplantation (HT) is unknown. This study examined long-term clinical outcomes after ACEI in HT recipients.MethodsThe ACEI after HT study was a prospective, randomized trial that tested the efficacy of ACEI with ramipril after HT. In this study, long-term clinical outcomes were assessed in 91 patients randomized to either ramipril or placebo (median, 5.8 years). The primary endpoint was a composite of death, retransplantation, hospitalization for rejection or heart failure, and coronary revascularization.ResultsThe primary endpoint occurred in 10 of 45 patients (22.2%) in the ramipril group and in 14 of 46 patients (30.4%) in the placebo group (Hazard ratio (HR), 0.68; 95% CI, 0.29–1.51; P = .34). When the analysis was restricted to comparing patients who remained on a renin-angiotensin system inhibitor beyond one year with those who did not, there was a trend to improved outcomes (HR, 0.54; 95% CI, 0.22–1.28, P = .16). There was no significant difference in creatinine, blood urea nitrogen, and potassium at 3 years after randomization. The cumulative incidence of the primary endpoint was significantly higher in patients in whom the index of microcirculatory resistance increased from baseline to one year compared with those in whom it did not (39.1 vs 17.4%, HR: 3.36; 95% CI, 1.07–12.7; P = .037).ConclusionThe use of ramipril after HT safely lowers blood pressure and is associated with favorable long-term clinical outcomes.
       
  • Outcomes following Cardioversion for patients with cardiac amyloidosis and
           atrial fibrillation or atrial flutter
    • Abstract: Publication date: Available online 8 January 2020Source: American Heart JournalAuthor(s): Rahul S Loungani, Michael R. Rehorn, Kyle R. Geurink, Amanda C. Coniglio, Eric Black-Maier, Sean D. Pokorney, Michel G. KhouriAbstractAtrial arrhythmias commonly occur in patients with cardiac amyloidosis (CA), but there is limited data on safety or efficacy of cardioversion (DCCV) for management of these rhythms in CA. We identified 25 patients with CA (20 with transthyretin (TTR) and 5 with light-chain (AL) amyloidosis) at Duke University who underwent DCCV for atrial arrhythmias and documented procedural success, complications, and long-term morbidity and mortality. While DCCV successfully restored sinus rhythm in 96% of patients, 36% of patients experienced immediate procedural complications (primarily bradycardia and hypotension), 80% had recurrence of atrial arrhythmias at one year, and 52% died at 3 years, highlighting short-term safety concerns, long-term inefficacy, and poor prognosis associated with symptomatic atrial arrhythmias requiring DCCV in CA.
       
  • Impact of Rejection-Related Immune Responses on the Initiation and
           Progression of Cardiac Allograft Vasculopathy
    • Abstract: Publication date: Available online 8 January 2020Source: American Heart JournalAuthor(s): Michael Dandel, Roland HetzerAbstractGiven the causal association between acute rejection (AR) and CAV, early detection of AR, selection of appropriate rejection management strategies and close monitoring of AR therapy results, can delay the development and/or aggravation of CAV. Due to the complexity of AR surveillance, no single invasive or noninvasive diagnostic method can provide all the needed information for preventing AR-related coronary vascular damages. Certain combinations of available non-invasive surveillance techniques can detect patients at imminent risk for AR and therefore enable the replacement of unnecessary routine surveillance endomyocardial biopsies (EMBs) by a lower number of diagnostic EMBs and also help for severity grading of biopsy-proven AR. Decisions about the need for AR therapy, selection of therapies, and determination of therapy duration can also help to delay the development and progression of CAV. Regarding this, the search for antibody-mediated rejection in all EMBs is mandatory and the use of certain non-invasive surveillance methods like sensitive echocardiographic techniques, monitoring of complement-activating donor specific antibodies and gene expression analysis can be particularly useful. Given its ability to identify patients at high risk for future rejections, gene expression analysis also facilitates an individualized immunosuppression. This article gives an overview of the current knowledge about the immunology of CAV and its linkage with AR. Special attention is focused on the impact of asymptomatic early and late low-grade ARs on the pathogenesis and the course of CAV. Overall, the review aimed to provide a theoretical and practical basis for all those engaged in this particularly demanding up-to-date topic.
       
  • Interim effects of salt substitution on urinary electrolytes and blood
           pressure in the China Salt Substitute and Stroke Study (SSaSS)
    • Abstract: Publication date: Available online 7 January 2020Source: American Heart JournalAuthor(s): Liping Huang, Maoyi Tian, Jie Yu, Qiang Li, Yishu Liu, Xuejun Yin, Jason HY Wu, Matti Marklund, Yangfeng Wu, Nicole Li, Paul Elliot, Lijing L. Yan, Darwin R. Labarthe, Zhixin Hao, Jingpu Shi, Xiangxian Feng, Jianxin Zhang, Yuhong Zhang, Ruijuan Zhang, Bo ZhouAbstractThe Salt Substitute and Stroke Study is an ongoing 5-year large-scale cluster randomized trial investigating the effects of potassium-enriched salt substitute compared to usual salt on the risk of stroke. The study involves 600 villages and 20,996 individuals in rural China.Intermediate risk markers were measured in a random subsample of villages every 12 months over 3 years to track progress against key assumptions underlying study design. Measures of 24-hour urinary sodium, 24-hour urinary potassium, blood pressure and participants’ use of salt substitute were recorded, with differences between intervention and control groups estimated using generalized linear mixed models. The primary outcome of annual event rate in the two groups combined was determined by dividing confirmed fatal and non-fatal strokes by total follow-up time in the first 2 years.The mean differences (95% confidence interval) were -0.32 g (-0.68 to 0.05) for 24-hour urinary sodium, +0.77 g (+0.60 to +0.93) for 24-hour urinary potassium, -2.65 mmHg (-4.32 to -0.97) for systolic blood pressure and +0.30 mmHg (-0.72 to +1.32) for diastolic blood pressure. Use of salt substitute was reported by 97.5% in the intervention group versus 4.2% in the control group (P
       
  • Risk of Major Cardiovascular and Neurologic Events with Obstructive Sleep
           Apnea among Patients with Atrial Fibrillation
    • Abstract: Publication date: Available online 7 January 2020Source: American Heart JournalAuthor(s): Frederik Dalgaard, MR Rebecca North, Karen Pieper, Gregg C. Fonarow, Peter R. Kowey, Bernard J. Gersh, Kenneth W. Mahaffey, Sean Pokorney, Benjamin A. Steinberg, Gerald Naccarrelli, Larry A. Allen, James A. Reiffel, Michael Ezekowitz, Daniel E. Singer, Paul S. Chan, Eric D. Peterson, Jonathan P. PicciniStructured AbstractBackgroundObstructive sleep apnea (OSA) is a known risk factor for atrial fibrillation (AF). However, it remains unclear whether OSA is independently associated with worse cardiovascular and neurological outcomes in patients with AF.MethodWe used the ORBIT-AF I and ORBIT-AF II to conduct a retrospective cohort study of 22,760 patients with AF with and without OSA. Adjusted multivariable Cox proportional hazards models was used to determine whether OSA was associated with increased risk for major adverse cardiac and neurologic events (MACNE) (cardiovascular death, myocardial infarction, stroke/transient ischemic attack/non-CNS embolism (stroke/SE), and new-onset heart failure) , combined and individually.ResultsA total of 4,045 (17.8%) patients had OSA at baseline. Median follow-up time was 1.5 (IQR: 1-2.2) years and 1,895 patients experienced a MACNE event. OSA patients were younger (median [IQR] 68 [61-75] years vs. 74 [66-81] years, were more likely male (70.7% vs. 55.3%), and had increased BMI (median 34.6 kg/m2 [29.8-40.2] vs. 28.7 kg/m2 [25.2-33.0]). Those with OSA had a higher prevalence of concomitant comorbidities such as diabetes, chronic obstructive pulmonary disease, and heart failure. OSA patients had higher use of antithrombotic therapy. After adjustment, the presence of OSA was significantly associated with MACNE (HR: 1.16 [95% CI: 1.03-1.31], p=0.011). OSA was also an independent risk factor for stroke/SE beyond the CHA2DS2-VASc risk factors (HR: 1.38 [95% CI 1.12-1.70], p=0.003), but not cardiovascular death, myocardial infarction, new-onset heart failure or major bleeding.ConclusionAmong patients with AF, OSA is an independent risk factor for MACNE and, more specifically, stroke/SE.Graphical AbstractUnlabelled Image
       
  • Complex High and Indicated Percutaneous Coronary Intervention for Stable
           Angina: Does Operator Volume Influence Patient Outcome'
    • Abstract: Publication date: Available online 7 January 2020Source: American Heart JournalAuthor(s): Tim Kinnaird, Sean Gallagher, James C. Spratt, Peter Ludman, Mark de Belder, Samuel Copt, Richard Anderson, Simon Walsh, Colm Hanratty, Nick Curzen, Adrian Banning, Mamas MamasBackgroundComplex high-risk and indicated revascularisation using percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly studied.ObjectivesTo define temporal changes in CHIP-PCI volumes, and the relationship between operator CHIP-PCI volume and patient outcomes.Methods and ResultsData were analysed on all CHIP-PCI procedures undertaken for stable angina in England and Wales between 2007 and 2014. Operator volume data was available for 2012-14. CHIP-PCI was defined by patient characteristics (age ≥80years, left ventricular (LV) ejection fraction
       
  • The mechanisms of recurrent atrial arrhythmias after second-generation
           cryoballoon ablation
    • Abstract: Publication date: March 2020Source: American Heart Journal, Volume 221Author(s): Shinsuke Miyazaki, Tomoki Horie, Hitoshi Hachiya, Kanae Hasegawa, Takatsugu Kajiyama, Tomonori Watanabe, Hiroaki Nakamura, Eri Ishikawa, Moe Mukai, Daisetsu Aoyama, Minoru Nodera, Kenichi Kaseno, Yoshito Iesaka, Hiroshi TadaBackgroundIn patients with paroxysmal atrial fibrillation (PAF), 10%-15% of patients require repeat procedures after second-generation cryoballoon pulmonary vein isolation (CB-PVI). We sought to explore the mechanisms of recurrences after cryoballoon ablation.MethodsThe data of 122 PAF patients who underwent second procedures for recurrent arrhythmias 7.0 (4.0-12.0) months after the CB-PVI were analyzed. During second procedures, non-PV AF foci were explored with isoproterenol, adenosine, and repetitive cardioversions.ResultsIn total, 378/487 (77.6%) PVs remained isolated, and reconnections were not observed in any PVs in 59 (48.4%) patients. PV reconnections were associated with recurrences in 38 (31.1%) patients, of whom 33 (86.8%) had reconnections of at least 1 upper PV. In 6 (4.9%) patients, non-PV AF foci were identified in the upper PV antra where cryoballoons cannot isolate but within the circumferential radiofrequency PVI line. Non-PV AF foci were identified in the superior vena cava, right atrial body, left atrial body, and atrial septum in 28 (23.0%), 18 (14.7%), 4 (3.3%), and 5 (4.1%) patients, respectively. Twelve (9.8%) patients had multiple non-PV AF foci. Four (3.3%), 3 (2.4%), and 8 (6.5%) patients underwent second procedures for atrioventricular nodal reentrant tachycardia, atrial flutter, and atrial tachycardias. During 16.0 (8.0-24.0) months of follow-up, freedom from any atrial arrhythmia at 1 year and 2 years after the second procedure was 79.2% and 60.6%. Nineteen (15.5%) patients had antiarrhythmic drug therapy at the last follow-up.ConclusionsOur study suggested that improvement in the upper PV PVI durability, eliminating arrhythmogenic superior vena cavae and coexisting atrial arrhythmias, and bonus cryoballoon applications at PV antra might improve the single procedure outcome in cryoballoon ablation.
       
  • Association between frequency of primary care provider visits and
           evidence-based statin prescribing and statin adherence: Findings from the
           Veterans Affairs system
    • Abstract: Publication date: March 2020Source: American Heart Journal, Volume 221Author(s): Sarah T. Ahmed, Dhruv Mahtta, Hasan Rehman, Julia Akeroyd, Mahmoud Al Rifai, Fatima Rodriguez, Hani Jneid, Khurram Nasir, Zainab Samad, Mahboob Alam, Laura A. Petersen, Salim S. ViraniBackgroundStatin use remains suboptimal in patients with atherosclerotic cardiovascular disease (ASCVD). We assessed if the frequency of visits with primary care providers (PCPs) is associated with higher use of evidence-based statin prescriptions and adherence among patients with ASCVD.MethodsWe identified patients with ASCVD aged ≥18 years receiving care in 130 facilities and associated community-based outpatient clinics in the entire Veterans Affairs Health Care System between October 1, 2013 and September 30, 2014. Patients were divided into frequent PCP visitors (annual PCP visits ≥ median number of PCP visits for the entire cohort) and infrequent PCP visitors (annual PCP visits < median number of patient visits). We assessed any- and high-intensity statin prescription as well as statin adherence which was defined by proportion of days covered (PDC).ResultsWe included 1,249,061 patients with ASCVD (mean age was 71.9 years; 98.0% male). Median number of annual PCP visits was 3. Approximately 80.1% patients were on statins with 23.8% on high-intensity statins. Mean PDC was 0.715 ± 0.336 with 58.3% patients with PDC ≥0.8. Frequent PCP visitors had higher frequency of statin use (82.2% vs 77.4%), high-intensity statin use (26.4% vs 20.3%), and statin adherence (mean PDC 0.73 vs 0.68; P 
       
  • Rationale and design of the British Heart Foundation (BHF) Coronary
           Microvascular Function and CT Coronary Angiogram (CorCTCA) study
    • Abstract: Publication date: March 2020Source: American Heart Journal, Volume 221Author(s): Novalia P Sidik, Margaret McEntegart, Giles Roditi, Thomas J Ford, Michael McDermott, Andrew Morrow, John Byrne, Jacqueline Adams, Allister Hargreaves, Keith G Oldroyd, David Stobo, Olivia Wu, Claudia-Martina Messow, Alex McConnachie, Colin BerryBackgroundMicrovascular and/or vasospastic anginas are relevant causes of ischemia with no obstructive coronary artery disease (INOCA) in patients after computed tomography coronary angiography (CTCA).ObjectivesOur research has 2 objectives. The first is to undertake a diagnostic study, and the second is to undertake a nested, clinical trial of stratified medicine.DesignA prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03477890) will be performed. All-comers referred for clinically indicated CTCA for investigation of suspected coronary artery disease (CAD) will be screened in 3 regional centers. Following informed consent, eligible patients with angina symptoms are enrolled before CTCA and remain eligible if CTCA excludes obstructive CAD.Diagnostic study: Invasive coronary angiography involving an interventional diagnostic procedure (IDP) to assess for disease endotypes: (1) angina due to obstructive CAD (fractional flow reserve ≤0.80); (2) microvascular angina (coronary flow reserve 25); (3) microvascular angina due to small vessel spasm (acetylcholine); (4) vasospastic angina due to epicardial coronary spasm (acetylcholine); and (5) noncoronary etiology (normal coronary function). The IDP involves direct invasive measurements using a diagnostic coronary guidewire followed by provocation testing with intracoronary acetylcholine. The primary outcome of the diagnostic study is the reclassification of the initial CTCA diagnosis based on the IDP.Stratified medicine trial: Participants are immediately randomized 1:1 in the catheter laboratory to therapy stratified by endotype (intervention group) or not (control group). The primary outcome of the trial is the mean within-subject change in Seattle Angina Questionnaire score at 6 months.Secondary outcomes include safety, feasibility, diagnostic utility (impact on diagnosis and certainty), and clinical utility (impact on treatment and investigations). Health status assessments include quality of life, illness perception, anxiety-depression score, treatment satisfaction, and physical activity. Participants who are not randomized will enter a follow-up registry. Health and economic outcomes in the longer term will be assessed using electronic patient record linkage.ValueCorCTCA will prospectively characterize the prevalence of disease endotypes in INOCA and determine the clinical value of stratified medicine in this population.Graphical abstractUnlabelled Image
       
  • Impact of EMpagliflozin on cardiac function and biomarkers of heart
           failure in patients with acute MYocardial infarction—The EMMY trial
    • Abstract: Publication date: March 2020Source: American Heart Journal, Volume 221Author(s): Norbert J Tripolt, Ewald Kolesnik, Peter N Pferschy, Nicolas Verheyen, Klemens Ablasser, Sandra Sailer, Hannes Alber, Rudolf Berger, Carl Kaulfersch, Katharina Leitner, Michael Lichtenauer, Arthur Mader, Deddo Moertl, Abderrahim Oulhaj, Christian Reiter, Thomas Rieder, Christoph H. Saely, Jolanta Siller-Matula, Franz Weidinger, Peter M ZechnerBackgroundSodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.MethodsWithin a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.DiscussionThe EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.
       
  • Transesophageal echocardiography complications associated with
           interventional cardiology procedures
    • Abstract: Publication date: March 2020Source: American Heart Journal, Volume 221Author(s): Afonso B. Freitas-Ferraz, Josep Rodés-Cabau, Lucía Junquera Vega, Jonathan Beaudoin, Kim O'Connor, Pierre Yves Turgeon, Jean-Michel Paradis, Alfredo Ferreira-Neto, Lluis Asmarats, Jean Champagne, Gilles O'Hara, Mathieu BernierBackgroundAlthough there have been several reports documenting complications related with transesophageal echocardiography (TEE) manipulation following cardiac surgery, there is a paucity of data regarding the safety of TEE used to guide catheter-based interventions. The aim of this study was to determine the prevalence, types and risk factors of complications associated with procedures requiring active TEE guidance.MethodsThis study included 1249 consecutive patients undergoing either transcatheter aortic valve implantation (TAVI), Mitraclip, left atrial appendage occlusion (LAAO) or paravalvular leak closure (PVLC). Patients were divided into 2 cohorts based on the degree of probe manipulation required to guide the procedure and the risk of developing a TEE-related complication: low-risk (TAVI, n = 1037) and high-risk (Mitraclip, LAAO and PVLC, n = 212). Patients were further analyzed according to the occurrence of major and minor TEE-related complications.ResultsThe overall incidence of TEE-related complications was 0.9% in the TAVI group and 6.1% in the rest of the cohort (P 
       
  • Association of plasma-soluble ST2 and galectin-3 with cardiovascular
           events and mortality following cardiac surgery
    • Abstract: Publication date: February 2020Source: American Heart Journal, Volume 220Author(s): Dipal M. Patel, Heather Thiessen-Philbrook, Jeremiah R. Brown, Eric McArthur, Dennis G. Moledina, Sherry G. Mansour, Michael G. Shlipak, Jay L. Koyner, Peter Kavsak, Richard P. Whitlock, Allen D. Everett, David J. Malenka, Amit X. Garg, Steven G. Coca, Chirag R. ParikhBackgroundCardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant post-operative morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) and galectin-3 (gal-3) are biomarkers of myocardial remodeling and fibrosis; however, their potential association with post-operative changes is unknown.MethodsWe measured peri-operative plasma sST2 and gal-3 levels in two prospective cohorts (TRIBE-AKI and NNE) of over 1800 patients who underwent cardiac surgery. sST2 and gal-3 levels were evaluated for association with a composite primary outcome of cardiovascular event or mortality over median follow-up periods of 3.4 and 6.0 years, respectively, for the two cohorts. Meta-analysis of hazard ratio estimates from the cohorts was performed using random effects models.ResultsCohorts demonstrated event rates of 70.2 and 66.8 per 1000 person-years for the primary composite outcome. After adjustment for clinical covariates, higher post-operative sST2 and gal-3 levels were significantly associated with cardiovascular event or mortality [pooled estimate HRs: sST2 1.29 (95% CI 1.16, 1.44); gal-3 1.26 (95% CI 1.09, 1.46)]. These associations were not significantly modified by pre-operative congestive heart failure or AKI.ConclusionsHigher post-operative sST2 and gal-3 values were associated with increased incidence of cardiovascular event or mortality. These two biomarkers should be further studied for potential clinical utility for patients undergoing cardiac surgery.Graphical abstractUnlabelled Image
       
  • A randomized, double-blind, placebo-controlled trial investigating the
           effect of ticagrelor on saphenous vein graft patency in patients
           undergoing coronary artery bypass grafting surgery—Rationale and design
           of the POPular CABG trial
    • Abstract: Publication date: February 2020Source: American Heart Journal, Volume 220Author(s): Laura M. Willemsen, Paul W.A. Janssen, Chris M. Hackeng, Johannes C. Kelder, Jan G.P. Tijssen, Albert H.M. van Straten, Mohammed A. Soliman-Hamad, Vera H.M. Deneer, Edgar J. Daeter, Uday Sonker, Patrick Klein, Jurriën M. ten BergRationaleAn estimated 15% of saphenous vein grafts (SVGs) occlude in the first year after coronary artery bypass grafting (CABG) despite aspirin therapy. Graft occlusion can result in symptoms, myocardial infarction, and death. SVG occlusion is primarily caused by atherothrombosis, in which platelet activation plays a pivotal role. Evidence regarding the effect of stronger platelet inhibition on SVG patency after CABG is limited. The main objective of the POPular CABG trial is to determine whether dual antiplatelet therapy with aspirin plus ticagrelor improves SVG patency when compared to aspirin alone.StudyThe POPular CABG is a randomized, double-blind, placebo-controlled, multicenter trial investigating the effect of adding ticagrelor to standard aspirin therapy on the rate of SVG occlusion. A total of 500 patients undergoing CABG with ≥ 1 SVG are randomized to ticagrelor or placebo. The primary end point is SVG occlusion rate, assessed with coronary computed tomography angiography at 1 year. Secondary end points are stenoses and occlusions in both SVGs and arterial grafts and SVG failure at 1 year, defined as a composite of SVG occlusion on coronary computed tomography angiography or coronary angiography, SVG revascularization, myocardial infarction in the territory supplied by an SVG, or sudden death. Safety end points are bleeding events at 30 days and 1 year.ConclusionThe POPular CABG trial investigates whether adding ticagrelor to standard aspirin after CABG reduces the rate of SVG occlusion at 1 year.
       
  • Central venous pressure and the risk of diuretic-associated acute kidney
           injury in patients after cardiac surgery
    • Abstract: Publication date: Available online 27 December 2019Source: American Heart JournalAuthor(s): Ian E. McCoy, Maria E. Montez-Rath, Glenn M. Chertow, Tara I. ChangAbstractBackgroundWhen prescribing diuretics in the post-cardiac surgical intensive care unit (ICU), clinicians may use central venous pressure (CVP) to assess volume status and the risk of acute kidney injury (AKI). In this study, we examined how the risk of diuretic-associated AKI varied with CVP in patients undergoing cardiac surgery.MethodsWe used the MIMIC-III database to study adults admitted to the post-cardiac surgical ICU at an urban, academic medical center between 2001 and 2012. We examined the odds of AKI per 1 mmHg increase in CVP among patients receiving intravenous loop diuretics using multivariable adjusted logistic regression. We examined the risk of AKI among patients with diuretic use (versus non-use) across tertiles of CVP using inverse probability treatment weighting.ResultsAmong 4164 patients receiving intravenous loop diuretics, the adjusted odds of subsequent AKI were 1.11 (95% confidence interval [CI] 1.08–1.13) times higher per mmHg increase in mean CVP. This association was log-linear across the entire range of CVPs observed. In the analysis of diuretic use (n = 5396), the adjusted risk ratio for AKI with diuretic use (versus non-use) was 1.33 (95% CI 1.21–1.47), and did not materially differ across tertile of CVP.ConclusionsHigher rather than lower CVP is an independent marker of AKI risk. The risk of AKI associated with diuretic use may not be influenced by CVP. Novel methods of assessing volume status and AKI risk are needed to guide patient selection for diuretic therapy.
       
  • Rationale and Design of the Flow Evaluation to Guide Revascularization in
           Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial
    • Abstract: Publication date: Available online 27 December 2019Source: American Heart JournalAuthor(s): Etienne Puymirat, Tabassome Simon, Bernard de Bruyne, Gilles Montalescot, Gabriel Steg, Guillaume Cayla, Isabelle Durand-Zaleski, Didier Blanchard, Nicolas Danchin, Gilles Chatellier, FLOWER-MI study investigatorsAbstractBackgroundIn ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients.Trial designFLOWER MI is an open label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5-Day). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power.ConclusionThe aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.ClinicalTrials.gov Identifier: NCT02943954
       
  • Feasibility of combining serial smartphone single-Lead electrocardiograms
           for the diagnosis of ST-elevation myocardial infarction
    • Abstract: Publication date: Available online 27 December 2019Source: American Heart JournalAuthor(s): Joseph Boone Muhlestein, Jeffrey L. Anderson, Charles F. Bethea, Harry W. Severance, Robert J. Mentz, Gregory W. Barsness, Alejandro Barbagelata, David Albert, Viet T. Le, T. Jared Bunch, Frank Yanowitz, Heidi T. May, Benjamin Chisum, Brianna S. Ronnow, Joseph Brent Muhlestein, Duke University Cooperative Cardiovascular Society (DUCCS) investigatorsAbstractBackgroundThe rate-limiting step in STEMI diagnosis often is the availability of a 12-lead electrocardiogram (ECG) and its interpretation. The potential may exist to speed the availability of 12-lead ECG information by using commonly available mobile technologies. We sought to test whether combining serial smartphone single-lead ECGs to create a virtual 12-lead ECG can accurately diagnose STEMI.MethodsConsenting patients presenting with symptoms consistent with a possible STEMI had contemporaneous standard 12-lead and smartphone ‘12-lead equivalent’ ECG (produced by electronically combining serial single-lead ECGs) recordings obtained. Matched ECGs were evaluated qualitatively and quantitatively by a panel of blinded readers and classified as STEMI/STEMI equivalent (LBBB), Not-STEMI, or uninterpretable. Interpretable ECG pairs were graded as showing good, fair, or poor correlation.Results204 subjects (age = 60 years, males = 57%, STEMI activation = 45%) were enrolled from 5 international sites. Smartphone ECG quality was graded as good in 151 (74.0%), fair in 32 (15.7%), poor in 8 (3.9%), and uninterpretable in 13 (6.4%). A STEMI/STEMI equivalent diagnosis was identified by standard 12-lead ECG in 57/204 (27.9%) recordings. For all interpretable pairs of smartphone ECGs compared with standard ECGs (n = 190), the sensitivity, specificity, and positive and negative predictive values for STEMI/STEMI equivalent by smartphone were 0.89, 0.84, 0.70 and 0.95, respectively.ConclusionsA ‘12-lead equivalent’ ECG obtained from multiple serial single-lead ECGs from a smartphone can identify STEMI with good correlation to a standard 12-lead ECG. This technology holds promise to improve outcomes in STEMI by enhancing the reach and speed of diagnosis and thereby early treatment.
       
  • Modeling defibrillation benefit for survival among cardiac
           resynchronization therapy defibrillator recipients
    • Abstract: Publication date: Available online 27 December 2019Source: American Heart JournalAuthor(s): Kenneth C. Bilchick, Yongfei Wang, Jeptha P. Curtis, Alan Cheng, Kumar Dharmarajan, Ramin Shadman, Todd F Dardas, Inder Anand, Lars H. Lund, Ulf Dahlström, Ulrik Sartipy, Aldo Maggioni, Christopher O'Connor, Wayne C. LevyBackgroundPatients with heart failure having a low expected probability of arrhythmic death may not benefit from implantable cardioverter defibrillators (ICDs).ObjectiveThe objective was to validate models to identify cardiac resynchronization therapy (CRT) candidates who may not require CRT devices with ICD functionality.MethodsHeart failure (HF) patients with CRT-Ds and non-CRT ICDs from the National Cardiovascular Data Registry and others with no device from 3 separate registries and 3 heart failure trials were analyzed using multivariable Cox proportional hazards regression for survival with the Seattle Heart Failure Model (SHFM; estimates overall mortality) and the Seattle Proportional Risk Model (SPRM; estimates proportional risk of arrhythmic death).ResultsAmong 60,185 patients (age 68.6 ± 11.3 years, 31.9% female) meeting CRT-D criteria, 38,348 had CRT-Ds, 11,389 had non-CRT ICDs, and 10,448 had no device. CRT-D patients had a prominent adjusted survival benefit (HR 0.52, 95% CI 0.50–0.55, P 
       
  • Myocardial fibrosis and the effect of primary prophylactic defibrillator
           implantation in patients with non-ischemic systolic heart failure –
           DANISH-MRI
    • Abstract: Publication date: Available online 24 December 2019Source: American Heart JournalAuthor(s): Marie Bayer Elming, Sophia Hammer-Hansen, Inga Voges, Eva Nyktari, Anna Axelsson Raja, Jesper Hastrup Svendsen, Steen Pehrson, James Signorovitch, Lars Køber, Sanjay K. Prasad, Jens Jakob ThuneAimsPatients with non-ischemic systolic heart failure have an increased risk of sudden cardiac death (SCD). Myocardial fibrosis, detected as late gadolinium enhancement (LGE) with cardiac magnetic resonance (CMR), has been shown to predict all-cause mortality. We hypothesized that LGE can identify patients with non-ischemic heart failure who will benefit from ICD implantation.Methods and resultsIn this prospective observational sub-study of the Danish Study to Assess the Efficacy of ICDs in Patients with Nonischemic Systolic Heart Failure on Mortality (DANISH), 252 patients underwent CMR. LGE was quantified by the full width/half maximum method. The primary endpoint was all-cause mortality. LGE could be adequately assessed in 236 patients, median age was 61 years and median duration of heart failure was 14 months; there were 108 patients (46%) randomized to ICD. Median follow-up time was 5.3 years. Median left ventricular ejection fraction on CMR was 35%. In all, 50 patients died. LGE was present in 113 patients (48%). The presence of LGE was an independent predictor of all-cause mortality (HR 1.82; 95% CI 1.002–3.29; P = .049) after adjusting for known cardiovascular risk factors. ICD implantation did not impact all-cause mortality, for either patients with LGE (HR 1.18; 95% CI 0.59–2.38; P = .63), or for patients without LGE (HR 1.00; 95% CI 0.39–2.53; P = .99), (p for interaction =0.79).ConclusionIn patients with non-ischemic systolic heart failure, LGE predicted all-cause mortality. However, in this cohort, LGE did not identify a group of patients who survived longer by receiving an ICD.
       
  • Cryoballoon catheter ablation versus antiarrhythmic drugs as a FIRST-line
           therapy for patients with paroxysmal atrial fibrillation: Rationale and
           Design of the International Cryo-FIRST study
    • Abstract: Publication date: Available online 18 December 2019Source: American Heart JournalAuthor(s): Jean Sylvain Hermida, Jian Chen, Christian Meyer, Saverio Iacopino, Giuseppe Arena, Nikola Pavlovic, Vedran Velagic, Stewart Healey, Douglas L. Packer, Heinz-Friedrich Pitschner, Carlo de Asmundis, Malte Kuniss, Gian Battista ChierchiaBackgroundRadiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF.ObjectivesThe Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups.MethodsThe primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1: 1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration>30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers.ConclusionsThis study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.Graphical abstractUnlabelled Image
       
  • Comparison of expected and observed outcomes for septal myectomy in
           hypertrophic obstructive cardiomyopathy
    • Abstract: Publication date: Available online 18 December 2019Source: American Heart JournalAuthor(s): Jeffrey B. Geske, C. Noelle Driver, Vidhushei Yogeswaran, Steve R. Ommen, Hartzell SchaffAbstractBackgroundSeptal myectomy remains the gold standard for treatment of symptomatic, medically-refractory hypertrophic cardiomyopathy (HCM). There is no specific surgical risk calculator for septal myectomy.MethodsThis study compares the outcomes of septal myectomy at a tertiary referral center with predicted outcomes of mitral valve (MV) repair and aortic valve replacement (AVR) using the Society of Thoracic Surgeons Adult Cardiac Surgery Risk Calculator (STS Calculator). 298 consecutive patients with HCM underwent isolated septal myectomy from 2011–2014. Observed outcomes of septal myectomy were compared with the STS Calculator predicted risk of isolated MV repair and AVR predicted within this population using one-sample tests of proportions.Results30-day mortality for myectomy in this cohort was zero. STS Calculator predicted risk of mortality for MV repair was 0.7% (P = .14) and for AVR = 1.1% (P = .06). Follow-up for vital status was 6.0 ± 0.7 years, at which 294 (98.7%) patients were alive. Hospital stay length was 4.9 ± 1.9 days. One (0.3%) patient experienced a post-operative deep sternal wound infection and one (0.3%) patient experienced a prolonged ventilated state. Post-operative atrial fibrillation occurred in 64 (21.4%) patients. During 30 days of follow-up, no patients experienced stroke, renal failure, or needed dialysis.ConclusionsSeptal myectomy, performed in a tertiary referral center, had a 30-day mortality rate of 0% and low morbidity rate. There was no difference between observed myectomy mortality and STS Calculator predicted risk for AVR and MV repair. It is possible that a larger sample could reveal lower mortality than STS prediction.
       
  • Identifying nonischemic cardiomyopathy patients who would benefit from an
           implantable Cardioverter-defibrillator: Can late gadolinium enhancement on
           cardiovascular magnetic resonance imaging help'
    • Abstract: Publication date: Available online 17 December 2019Source: American Heart JournalAuthor(s): Rajat Kalra, Chetan Shenoy
       
  • Consequences of impressive myectomy results in a Center of Excellence: The
           paradox of evidence-based medicine era
    • Abstract: Publication date: Available online 17 December 2019Source: American Heart JournalAuthor(s): Josef Veselka
       
  • Is there sex Bias against women reflected in industry payments and does it
           matter'
    • Abstract: Publication date: Available online 17 December 2019Source: American Heart JournalAuthor(s): Andrea M. Russo
       
  • Association of HDL particle concentration with cardiovascular risk
           following acute coronary syndrome: A case-cohort analysis of the
           dal-outcomes trial
    • Abstract: Publication date: Available online 16 December 2019Source: American Heart JournalAuthor(s): Taufiq Salahuddin, John Kittelson, Jean-Claude Tardif, Prediman K. Shah, Anders G. Olsson, Stephen J. Nicholls, Eran Leitersdorf, Lawrence A. Leiter, David Kallend, Donald M. Black, Philip J. Barter, Christie M. Ballantyne, Gregory G. SchwartzAbstractBackgroundHDL cholesterol (HDL-C) concentration is inversely related to risk of major adverse cardiovascular events (MACE) in epidemiologic studies but is a poorer predictor of MACE in patients with established coronary heart disease. HDL particle concentration (HDLP) has been proposed as a better predictor of risk. We investigated whether HDLP is associated with risk of MACE after acute coronary syndrome (ACS).MethodsThe dal-Outcomes trial compared the CETP inhibitor dalcetrapib with placebo in patients with recent ACS. In a nested case-cohort analysis, total, large, medium and small HDLP were measured by NMR spectroscopy at baseline (4–12 weeks after ACS) in 476 cases with MACE and 902 controls. Hazard ratios (HRs; case:control) for 1 standard deviation increment of HDLP or HDL-C at baseline were calculated with and without adjustment for demographic, clinical, laboratory, and treatment variables. Similarly, HRs for MACE were calculated for changes in HDLP or HDL-C from baseline to Month 3 of assigned treatment.ResultsOver median follow-up of 28 months, the risk of MACE was not associated with baseline HDLP (adjusted HR = 0.98, 95% confidence interval = 0.84–1.15, P = .81), any HDLP subclass or HDL-C. Dalcetrapib increased HDL-C and total, medium, and large HDLP and decreased small HDLP, but had no effect on MACE compared with placebo. There was no association of risk of MACE with change in HDLP or HDL-C and no interaction with assigned study treatment.ConclusionsNeither baseline HDLP nor the change in HDLP on treatment with dalcetrapib or placebo is associated with risk of MACE after ACS.
       
  • Corrigendum to “Randomized controlled trial of influenza vaccine in
           patients with heart failure to reduce adverse vascular events (IVVE):
           Rationale and design” [212 (2019) 36–44]
    • Abstract: Publication date: Available online 12 December 2019Source: American Heart JournalAuthor(s): Mark Loeb, Hisham Dokainish, Antonio Dans, Lia M Palileo-Villanueva, Ambuj Roy, Kamilu Karaye, Jun Zhu, Yan Liang, Fastone Goma, Albertino Damasceno, Khalid F AlHabib, Gerald Yonga, Charles Mondo, Wael Almahmeed, Arif Al Mulla, Salim Yusuf, IVVE investigators
       
  • Rationale and design of the steroids to reduce systemic inflammation after
           infant heart surgery (stress) trial
    • Abstract: Publication date: Available online 9 December 2019Source: American Heart JournalAuthor(s): Kevin D. Hill, H. Scott Baldwin, David P. Bichel, Ryan J. Butts, Reid C. Chamberlain, Alicia M. Ellis, Eric M. Graham, Jesse Hickerson, Christoph P. Hornik, Jeffrey P. Jacobs, Marshall L. Jacobs, Robert DB Jaquiss, Prince J. Kannankeril, Sean M. O'Brien, Rachel Torok, Joseph W. Turek, Jennifer S. Li, For the STRESS Network InvestigatorsFor decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the post-operative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double blind, multi-center trial designed to evaluate safety and efficacy of perioperative steroids in infants (age
       
  • Estimating the prevalence of congenital heart disease among adolescents
           and adults in Colorado adjusted for incomplete case ascertainment
    • Abstract: Publication date: Available online 5 December 2019Source: American Heart JournalAuthor(s): Lindsey M Duca, Laura Pyle, Amber D Khanna, Toan Ong, Michael G Kahn, Carolyn DiGuiseppi, Kenneth Scott, Matthew F Daley, Everett Costa, Arthur J Davidson, Tessa L CrumeBackgroundCongenital heart defects (CHDs), the most common type of birth defect in the United States, are increasing in prevalence in the general population. Though CHD prevalence at birth has been well described in the United States at about 1%, little is known about long-term survival and prevalence of CHDs beyond childhood. This study aimed to estimate the prevalence of CHDs among adolescents and adults in Colorado.MethodsThe prevalence of CHDs among adolescents and adults residing in Colorado during 2011–2013 was estimated using log-linear capture-recapture methods to account for incomplete case ascertainment. Five case-finding data sources were used for this analysis including electronic health record data from four major health systems and a state-legislated all payer claims database.Results12,293 unique individuals with CHDs (2481 adolescents and 9812 adults) were identified in one or more primary data sources. We estimated the crude prevalence of CHDs in adolescents and adults in Colorado to be 3.22 per 1000 individuals (95% CI 3.19–3.53). After accounting for incomplete case ascertainment, the final capture-recapture model yielded an estimated total adolescent and adult CHD population of 23,194 (95% CI 22,419-23,565) and an adjusted prevalence of 6.07 per 1000 individuals (95% CI 5.86–6.16), indicating 47% of the cases in the catchment area were not identified in the case-identifying data sources.ConclusionThis statewide study yielded new information on the prevalence of CHDs in adolescents and adults. These high prevalence rates underscore the need for additional specialized care facilities for this population with CHDs.
       
  • Impact of pre-procedural left ventricle hypertrophy and geometrical
           patterns on mortality following TAVR
    • Abstract: Publication date: Available online 30 November 2019Source: American Heart JournalAuthor(s): Zach Rozenbaum, Ariel Finkelstein, Sophia Zhitomirsky, Yan Topilsky, Amir Halkin, Shmuel Banai, Samuel Bazan, Israel Barbash, Amit Segev, Victor Guetta, Haim Danenberg, David Planner, Katia Orvin, Hana Vaknin Assa, Abid Assali, Ran Kornowski, Arie SteinvilBackgroundIn contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR).MethodsWe performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry, for whom pre-procedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: Normal LVMI, mild, moderate and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling).ResultsThe cohort consisted of 1559 patients, 46.5% males, with a mean age of 82.2(±6.8) years and mean LVMI of 121(±29) gr/m2. Rates of normal LVMI, mild, moderate and severe LVH were 31%(n = 485), 21%(n = 322), 18%(n = 279), and 30%(n = 475), respectively. Three-year mortality rates for normal LVMI, mild, moderate and severe LVH were 19.8%, 18.3%, 23.7%, 24.4%, respectively. Compared to mild LVH, moderate and severe LVH were independently associated with an increased risk for all-cause mortality (HR 1.58, 95%CI 1.15–2.18, P = .005; HR 1.46, 95%CI 1.1–1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI0.63–0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95%CI 1.11–1.60, P = .002).ConclusionMild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population.
       
  • Quantitative analysis of ablation technique predicts arrhythmia recurrence
           following atrial fibrillation ablation
    • Abstract: Publication date: Available online 27 November 2019Source: American Heart JournalAuthor(s): Lior Jankelson, Matthew Dai, Scott Bernstein, David Park, Douglas Holmes, Anthony Aizer, Larry Chinitz, Chirag BarbhaiyaBackgroundOptimal ablation technique, including catheter-tissue contact during atrial fibrillation (AF) radiofrequency (RF) ablation is associated with improved procedural outcomes. We used a custom developed software to analyze high frequency catheter position data to study the interaction between catheter excursion during lesion placement, lesion-set sequentiality and arrhythmia recurrence.Methods100 consecutive patients undergoing first time RF ablation for paroxysmal AF were analyzed. Spatial positioning of the ablation catheter sampled at 60 Hz during RF application was extracted from the CARTO3 system (Biosense Webster Inc., USA) and analyzed using custom developed MATLAB software to determine precise catheter spatial 3D excursion during RF ablation. The primary end point was freedom from atrial arrhythmia lasting longer than 30 seconds after a single ablation procedure.ResultsAt one year, 86% of patients were free from recurrent arrhythmia. There was no significant difference in clinical, echocardiographic or ablation characteristics between patients with and without recurrent arrhythmia. Analyzing 15,356,998 position data-points revealed that lesion-set sequentiality and mean lesion catheter excursion were predictors of arrhythmia recurrence. Analyzing arrhythmia recurrence by mean single-lesion catheter excursion (excursion>2.81 mm) and by sequentiality (using 46% of lesions with inter-lesion distance>6 mm as cutoff) revealed significantly increased arrhythmia recurrence in the higher excursion group (23% vs. 6%, P = .03) and in the less sequential group (24% vs. 4%, P = .02).ConclusionAblation lesion sequentiality measured by catheter inter-lesion distance and catheter stability measured by catheter excursion during lesion placement are potentially modifiable factors affecting arrhythmia recurrence after RF ablation for AF.
       
  • Safety and efficacy outcomes of left atrial Posterior Wall isolation
           compared to pulmonary vein isolation and pulmonary vein isolation with
           linear ablation for the treatment of persistent atrial fibrillation
    • Abstract: Publication date: Available online 22 November 2019Source: American Heart JournalAuthor(s): Joanne Sutter, Yuliya Lokhnygina, James P. Daubert, Tristram Bahnson, Kevin Jackson, Jason I. Koontz, Albert Y. Sun, Donald D. Hegland, Kevin L. Thomas, Larry Jackson, Robert Lewis, Christopher Granger, Jonathan P. Piccini, Brett D. AtwaterObjectivesTo compare outcomes of catheter ablation in patients with persistent atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI) with and without adjunctive posterior wall isolation (PWI).BackgroundPWI is increasingly used as an adjunctive lesion set to compliment PVI, especially in patients with persistent AF.MethodsWe performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF. Subjects were matched using propensity score adjustments. Outcomes were freedom from recurrent atrial arrhythmia and adverse events.ResultsAmong 558 patients who underwent ablation for persistent AF, 78 (14%) underwent PVI + PWI, 255 (46%) underwent PVI, and 225 (40%) underwent PVI + linear ablation. Stratified logistic regression analysis with propensity matching revealed higher odds of recurrent arrhythmia with PVI + PWI when compared to PVI (OR 2.25, 95% CI [1.08, 4.69], P = .030) and when compared to PVI + linear (OR 2.31, 95% CI [1.01, 5.28], P = .048). Within the PVI + PWI group, 57.7% of subjects were in NSR at 6 months compared to 73.9% and 72.2% in PVI and PVI + linear groups, respectively. Adverse events were rare, with 19 events total identified across all groups.ConclusionPVI + PWI does not appear to be as effective as PVI or PVI + linear ablation in reducing the recurrence of arrhythmia within 6 months of the index procedure in patients with persistent AF. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF.Condensed AbstractPWI is increasingly used as an adjunctive lesion set to compliment PVI in patients with persistent AF. We performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF to compare the outcomes between PVI with and without adjunctive PWI. We found an increased incidence in recurrence of AF and other atrial arrhythmias at 6 months in the PVI + PWI cohort compared to PVI with or without additional linear ablation. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF.
       
  • Major bleeding in patients with peripheral artery disease: Insights from
           the EUCLID trial
    • Abstract: Publication date: Available online 18 November 2019Source: American Heart JournalAuthor(s): Rachael Ward, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F. Gerry R. Fowkes, Brian G. Katona, Kenneth W. Mahaffey, Lars Norgren, Sreekanth Vemulapalli, Thomas J. Povsic, Rajendra Mehta, William R. Hiatt, Manesh R. Patel, W. Schuyler JonesBackgroundRates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post-hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events.Methods and ResultsEUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety endpoint was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. TIMI major bleeding occurred in 2.3% of participants overall (0.94 events/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and beta-blocker use. Patients with TIMI major bleeding post-randomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40–5.84; P 
       
  • Are existing and emerging biomarkers associated with cardiorespiratory
           fitness in patients with chronic heart failure'
    • Abstract: Publication date: Available online 16 November 2019Source: American Heart JournalAuthor(s): Marat Fudim, Jacob P. Kelly, Aaron D. Jones, Omar AbouEzzeddine, Andrew P. Ambrosy, Stephen J. Greene, Yogesh N.V. Reddy, Kevin J. Anstrom, Brooke Alhanti, Gregory D. Lewis, Adrian F. Hernandez, G. Michael FelkerAimsCardiorespiratory fitness (CRF) is closely linked to health status and clinical outcomes in heart failure (HF) patients. We aimed to test whether biomarkers can reflect CRF and its change over time.Methods and ResultsThis post-hoc analysis utilized data from ambulatory cohorts of heart failure with reduced ejection fraction (HFrEF) (IRONOUT) and heart failure with preserved ejection fraction (HFpEF) (RELAX). Cardiopulmonary exercise testing, 6 minute walk distance (6MWD), and serum biomarkers were measured at baseline and 16 or 24 week follow-up (for IRONOUT and RELAX respectively). Biomarkers included N-terminal pro–B-type natriuretic peptide (NT-proBNP), soluble ST2, growth differentiation factor-15 (GDF-15), and galectin-3. Analysis included 225 patients with HFrEF and 216 with HFpEF. Baseline peak VO2, VE/VCO2 slope and 6MWD showed a mild correlation with the doubling of all four tested biomarkers in HFrEF and HFpEF. Following multivariable adjustment (including all biomarkers), the only significant association between change in biomarker and functional parameter in HFrEF was change in NT-proBNP and change in VE/VCO2 slope (3.596% increase per doubling, 95%CI [0.779, 6.492]; P = .012). In HFpEF a decrease in peak VO2 was associated with an increase in NT-proBNP (−0.726 ml/min/kg per doubling, 95%CI [−1.100, −0.353]; P 
       
  • The accuracy of self-reported blood pressure in the medication adherence
           improvement support app for engagement – Blood pressure (MedISAFE-BP)
           trial: Implications for pragmatic trials
    • Abstract: Publication date: Available online 14 November 2019Source: American Heart JournalAuthor(s): Nancy Haff, Julie C. Lauffenburger, Kyle Morawski, Roya Ghazinouri, Nudrat Noor, Shefali Kumar, Jessie Juusola, Niteesh K. ChoudhrySelf-report of health conditions and behaviors is one potential strategy to increase the pace of enrollment into pragmatic clinical trials. In this study, we assessed the accuracy of self-reported poorly-controlled hypertension among adults in the community who were screened for participation in the MedISAFE-BP trial. Of individuals who self-reported poorly-controlled hypertension using the online trial enrollment platform, 64% had a systolic blood pressure less than 140 mmHg when measured at home. While we identified several characteristics associated with accurate self-report including older age (Odds Ratio [OR] 1.02 per year, 95% CI 1.01–1.03), diabetes (OR 1.59, 95% CI 1.17–2.14), and low health activation (OR 1.56 95% CI 1.17–2.07), we were unable to identify patients for whom self-reported hypertension would be a reliable method for their inclusion in a pragmatic trial.
       
  • Low-density lipoprotein cholesterol treatment and outcomes in patients
           with type 2 diabetes and established cardiovascular disease: Insights from
           TECOS
    • Abstract: Publication date: Available online 13 November 2019Source: American Heart JournalAuthor(s): Gaetano M. De Ferrari, Susanna R. Stevens, Giuseppe Ambrosio, Sergio Leonardi, Paul W. Armstrong, Jennifer B. Green, Malgorzata Wamil, Rury R. Holman, Eric D. Peterson, on behalf of the TECOS Study GroupBackgroundType 2 diabetes (T2D) patients are at increased risk for cardiovascular (CV) events. Most guidelines recommend treating low-density lipoprotein cholesterol (LDL-C) levels to ≤70 mg/dL (1.8 mM) for patients with T2D and established atherosclerotic CV disease, and some a more aggressive target of ≤55 mg/dL (1.4 mM). Our objective was to assess the degree to which these LDL-C targets are achieved in routine practice.MethodsUsing data from TECOS, an international pragmatic CV outcomes trial of sitagliptin vs placebo, we assessed lipid-lowering treatment among patients with T2D and CV disease, baseline lipid values, and the association between baseline LDL-C and 5-year risk for major adverse cardiac event (MACE; ie, CV death, nonfatal myocardial infarction, or nonfatal stroke).ResultsOverall, 11,066 of 14,671 TECOS participants (75.4%) had LDL-C measured at baseline. Median age was 65 years, 72% were male, and median T2D duration was 10 years. Overall, 82.5% of patients were on statins; only 5.8% were on ezetimibe. At baseline, 14.3% had an LDL-C ≤ 55 mg/dL, 18.4% between 55.1–70 mg/dL, 35% between 70.1–100 mg/dL, and 32.3%>100 mg/dL. Each 10 mg/dL higher LDL-C value was associated with a higher risk of MACE (HR 1.05, 95%CI 1.03–1.07) or CV death (HR 1.06, 95%CI 1.04–1.09).ConclusionsAlthough most high-risk patients with T2D and CV disease were on lipid-lowering therapy, only 1:3 had LDL-C 
       
  • Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed
           dyslipidemia: BEIJERINCK study design and baseline characteristics
    • Abstract: Publication date: Available online 12 November 2019Source: American Heart JournalAuthor(s): Franck Boccara, Princy Kumar, Bruno Caramelli, Alexandra Calmy, J. Antonio G. López, Sarah Bray, Marcoli Cyrille, Robert S. RosensonBackgroundPeople living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug–drug interactions with ART. Herein, we present the design and baseline characteristics of the BEIJERINCK study, which will assess the safety and efficacy of evolocumab in PLHIV and hypercholesterolemia/mixed dyslipidemia.MethodsRandomized, double-blind, placebo-controlled, multinational trial that investigates monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia who are treated with maximally-tolerated statin therapy. The primary outcome is the baseline to week 24 percent change in low density lipoprotein cholesterol (LDL-C). Secondary outcomes include achievement of LDL-C 
       
  • Videos to reduce racial disparities in ICD therapy via innovative designs
           (VIVID) trial: Rational, design and methodology
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Kevin L. Thomas, Lonnie T. Sullivan, Sana M. Al-Khatib, Nancy Allen LaPointe, Sam Sears, Andrzej S. Kosinski, Larry R. Jackson, Valentina Kutyifa, Eric D. PetersonBackgroundDespite a higher prevalence of sudden cardiac death (SCD), black individuals are less likely than whites to have an implantable cardioverter defibrillator (ICD) implanted. Racial differences in ICD utilization is in part explained by higher refusal rates in black individuals. Decision support can assist with treatment related uncertainty and prepare patients to make well informed decisions.MethodsThe Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) study will randomize 350 black individuals with a primary prevention indication for an ICD to a racially concordant/discordant video-based decision support tool or usual care. The composite primary outcome is, 1) the decision for ICD placement in the combined video groups compared with usual care and 2) the decision for ICD placement in the racially concordant relative to discordant video group. Additional outcomes include knowledge of ICD therapy and SCD risk, decisional conflict, ICD receipt at 90 days and a qualitative assessment of ICD decision making in acceptors, decliners and those undecided.ConclusionsIn addition to assessing the efficacy of decision support on ICD acceptance among black individuals, VIVID will provide insight into the role of racial concordance in medical decision-making. Given the similarities in the root causes of racial/ethnic disparities in care across health disciplines, our approach and findings may be generalizable to decision-making in other health care settings.
       
  • Average daily ischemic vs. bleeding risk in patients with ACS undergoing
           PCI: Insights from the Bleemacs and Renami registries
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Fabrizio D'Ascenzo, Carloalberto Biolè, Sergio Raposeiras-Roubin, Federico Gaido, Emad Abu-Assi, Tim Kinnaird, Albert Ariza-Solé, Christoph Liebetrau, Sergio Manzano-Fernández, Giacomo Boccuzzi, Jose Paulo Simao Henriques, Christian Templin, Stephen B. Wilton, Pierluigi Omedè, Lazar Velicki, Ioanna Xanthopoulou, Luis Correia, Enrico Cerrato, Andrea Rognoni, Ugo FabrizioAbstractIntroductionThe risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first-year of follow-up according to clinical presentation, medical and interventional strategies.MethodsBleeMACS and Renami are two multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary endpoints. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup.Results19,826 patients were included. Overall, in the first year after PCI the ADBR was 0.008085%, while ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with STEMI or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the 3rd month, while ADBR became higher, although not significantly, afterwards. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), while non-ST-elevation-ACS patients (NSTE-ACS) and those on ticagrelor had an excess of bleeding (P = .012 and P = .022 respectively).ConclusionsIn unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in STEMI patients and those with incomplete revascularization. In the first year ADIR was higher than ADBR in patients with incomplete revascularization, while ADBR was higher in NSTE-ACS patients and in those discharged on ticagrelor.
       
  • High throughout targeted proteomics discovery approach and spontaneous
           reperfusion in ST-segment elevation myocardial infarction
    • Abstract: Publication date: Available online 9 November 2019Source: American Heart JournalAuthor(s): Jay S. Shavadia, Christopher B. Granger, Wendimagegn Alemayehu, Cynthia M. Westerhout, Thomas J. Povsic, Sorin J. Brener, Sean van Diepen, Christopher Defilippi, Paul W. ArmstrongObjectivesTo explore associations between spontaneous reperfusion (SR) in ST-segment elevation myocardial infarction (STEMI) using a multi-marker cardiovascular proteins strategy.BackgroundAlthough SR prior to primary percutaneous coronary intervention (pPCI) is associated with improved outcomes, its pathophysiology remains unclear.MethodsWe evaluated STEMI patients from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI) trial treated with pPCI within 6 hours from symptom onset. SR was core-lab defined as pre-PCI Thrombolysis in Myocardial Infarction (TIMI) flow 2 or 3. Ninety-one cardiovascular disease-related serum biomarkers drawn prior to PCI were analyzed using a high throughput “targeted discovery” panel. Expression levels for individual biomarkers were compared between patients with/without SR. A hierarchical clustering method of biomarkers identified clusters of biomarkers that differentiated the two groups. Associations between individual biomarkers and clusters with SR were further evaluated by multivariable logistic regression.ResultsOf 683 patients studied, 290 had spontaneous reperfusion; those with compared to without SR were more likely non-inferior STEMI, had lower clinical acuity, and lower baseline levels of troponin and creatine kinase. SR was associated with a lower occurrence of 90-day composite of death, heart failure or cardiogenic shock. Fifty-two of 91 individual biomarkers were significantly univariably associated with SR. Forty-five remained significant with adjustment for false discovery rate. Using cluster analysis, 26 biomarkers clusters were identified, explaining 72% of total covariance, and 13 biomarker clusters were significantly associated with SR after multivariable adjustment. SR was associated with higher mean expression levels of proteins in all 13 clusters. The cluster most strongly associated with SR consisted of novel proteins across various distinct, yet inter-linked pathobiological processes (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3 and elafin).ConclusionSpontaneous reperfusion prior to pPCI in STEMI was associated with a lower risk of adverse clinical events. These exploratory data from a targeted discovery proteomics platform identifies novel proteins across diverse, yet complementary, pathobiological axes that show promise in providing mechanistic insights into spontaneous reperfusion in STEMI.Condensed abstractSpontaneous reperfusion has been established with improved STEMI outcomes, yet its pathobiology is unclear and appears to involve diverse physiological processes. Using a 91-biomarker high-throughput proteomics platform, we studied 683 STEMI patients in the APEX AMI trial (290 had core-lab adjudicated pre-PCI TIMI 2/3 flow) and identified 52 proteins that univariably associate with spontaneous reperfusion. Cluster analysis identified 26 biomarker clusters (explaining 72% of total variance), 13 of which, after multivariable adjustment, were significantly associated with spontaneous reperfusion. Four proteins (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3 and elafin) across diverse, yet complementary pathways, appear to be associated most strongly with spontaneous reperfusion.
       
  • The role of clinical assessment and electrophysiology study in Brugada
           Syndrome patients with syncope
    • Abstract: Publication date: Available online 8 November 2019Source: American Heart JournalAuthor(s): Jaime Hernandez-Ojeda, Elena Arbelo, Paloma Jorda, Roger Borras, Oscar Campuzano, Georgia Sarquella-Brugada, Anna Iglesias, Lluis Mont, Ramon Brugada, Josep BrugadaAbstractBackgroundCardiogenic syncope in Brugada syndrome (BrS) increases the risk of major events. Nevertheless, clinical differentiation between cardiogenic and vasovagal syncope can be challenging. We characterized the long-term incidence of major events in a large cohort of BrS patients presented with syncope.MethodsFrom a total of 474 patients, syncope was the initial manifestation in 135 (28.5%) individuals (43.9 ± 13.9 years, 71.1% male). The syncope was classified prospectively in cardiogenic, vasovagal or undefined if unclear characteristics were present. Clinical, electrocardiographic, genetic and electrophysiologic features were analyzed. Cardiogenic syncope, sustained ventricular arrhythmias and sudden death were considered major events in follow-up.ResultsIn 66 patients (48.9%) the syncope was cardiogenic, in 51 (37.8%) vasovagal and in 18 (13.3%) undefined. The electrophysiology study (EPS) inducibility was more frequent in patients with cardiogenic syncope and absent in all patients with undefined syncope (28[53.8%] vs. 5[12.2%] vs 0[0%]; P 
       
  • Sudden cardiac death in patients with Myocarditis: Evaluation, risk
           stratification, and management
    • Abstract: Publication date: Available online 15 August 2019Source: American Heart JournalAuthor(s): Fatima Ali-Ahmed, Frederik Dalgaard, Sana M. Al-KhatibAbstractMyocarditis is a major cause of sudden cardiac death (SCD) and dilated cardiomyopathy (DCM) in young adults. Cardiac magnetic resonance (CMR) is the established tool for the diagnosis of myocarditis, and late gadolinium enhancement (LGE) detected on CMR imaging is the strongest independent predictor of SCD, all-cause mortality, and cardiac mortality. Several other factors have been associated with SCD or cardiac transplantation including New York Heart Association functional class III/IV, reduced left ventricular ejection fraction (LVEF)
       
  • Gastrointestinal bleeding in patients with atrial fibrillation treated
           with Apixaban or warfarin: Insights from the ARISTOTLE trial
    • Abstract: Publication date: Available online 31 October 2019Source: American Heart JournalAuthor(s): David A. Garcia, Deborah A. Fisher, Hillary Mulder, Lisa Wruck, Raffele De Caterina, Sigrun Halvorsen, Christopher B. Granger, Claes Held, Lars Wallentin, John H. Alexander, Renato D. LopesAbstractObjectivesA history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. To sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with an increased risk of stroke or major hemorrhage.MethodsWe analyzed key efficacy and safety outcomes in patients with prior GIB in ARISTOTLE. Centrally adjudicated outcomes according to GIB history were analyzed using Cox proportional hazards models adjusted for randomized treatment and established risk factors.ResultsA total of 784 (4.3%) patients had prior GIB (321 [41%] lower, 463 [59%] upper); 215 (27%) occurred
       
  • Impact Of Initial Heart Failure Emergence On Clinical Outcomes Of Atrial
           Fibrillation Patients In the AFFIRM Trial
    • Abstract: Publication date: Available online 28 October 2019Source: American Heart JournalAuthor(s): April Slee, Sanjeev SaksenaAbstractBackgroundHeart failure (HF) emergence in atrial fibrillation (AF) patients undergoing different treatment strategies has not been studied.MethodsAFFIRM trial subjects with no history of HF, without clinical HF & normal left ventricular ejection fraction at enrollment were identified. The principal outcome was time to development of a composite of NYHA class ≥II HF &/or cardiovascular (CV) death. It was compared for Rate and Rhythm strategies and correlated with ECG parameters on follow up (FU).Results1771 patients (880 Rate, 891 Rhythm) were evaluated. The principal outcome occurred in 21.4% of Rate and 16.8% of Rhythm subjects at 5 years (HR 1.32, 95% confidence intervals {CI:} 1.04, 1.69, P = .024). HF inrement by 2 classes increased total mortality (HR 2.83, 95% CI 1.91, 4.18, P 
       
  • Patterns of Amiodarone use and outcomes in clinical practice for atrial
           fibrillation
    • Abstract: Publication date: Available online 23 October 2019Source: American Heart JournalAuthor(s): Sean D. Pokorney, DaJuanicia N. Holmes, Peter Shrader, Laine Thomas, Gregg C. Fonarow, Kenneth W. Mahaffey, Bernard J Gersh, Peter R. Kowey, Gerald V. Naccarelli, James V. Freeman, Daniel E. Singer, Jeffrey B. Washam, Eric D. Peterson, Jonathan P. Piccini, James A. ReiffelAbstractBackgroundAmiodarone is the most effective antiarrhythmic drug (AAD) for atrial fibrillation (AF), but it has a high incidence of adverse effects.MethodsUsing the ORBIT AF registry, patients with AF on amiodarone at enrollment, prescribed amiodarone during follow-up, or never on amiodarone were analyzed for the proportion treated with a guideline-based indication for amiodarone, the variability in amiodarone use across sites, and the outcomes (mortality, hospitalization, and stroke) among patients treated with amiodarone. Hierarchical logistic regression modeling with site-specific random intercepts compared rates of amiodarone use across 170 sites. A logistic regression model for propensity to receive amiodarone created a propensity-matched cohort. Cox proportional hazards modeling, stratified by matched pairs evaluated the association between amiodarone and outcomes.ResultsAmong 6987 AF patients, 867 (12%) were on amiodarone at baseline and 451 (6%) started on incident amiodarone during the 3-year follow-up. Use of amiodarone varied among sites from 3% in the lowest tertile to 21% in the highest (P 
       
  • Care Optimization Through Patient and Hospital Engagement Clinical Trial
           for Heart Failure: Rationale and Design of CONNECT-HF
    • Abstract: Publication date: Available online 23 October 2019Source: American Heart JournalAuthor(s): Adam D. DeVore, Bradi B. Granger, Gregg C. Fonarow, Hussein R. Al-Khalidi, Nancy M. Albert, Eldrin F. Lewis, Javed Butler, Ileana L. Piña, Paul A. Heidenreich, Larry A. Allen, Cyde W. Yancy, Lauren B. Cooper, G. Michael Felker, Lisa A. Kaltenbach, A. Thomas McRae, David E. Lanfear, Robert W. Harrison, Robb D. Kociol, Maghee Disch, Dan ArielyAbstractMany therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF (Care Optimization Through Patient and Hospital Engagement Clinical Trial for HF) study is a prospective, cluster-randomized trial of 161 hospitals in the United States with a 2x2 factorial design. The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective). The hospital and post-discharge intervention includes audit and feedback on HF clinical process measures and outcomes for patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts. The patient-level digital intervention is an optional ancillary study and includes a mobile application and behavioral tools that are intended to facilitate improved use of guideline-directed recommendations for self-monitoring and self-management of activity and medications for HFrEF. The effects of the interventions will be measured through an opportunity-based composite score on quality and time-to-first HF readmission or death among patients with HFrEF who present to study hospitals with acute HF and who consent to participate. The CONNECT-HF study is evaluating approaches for implementing HF guideline recommendations into practice and is one of the largest HF implementation science trials performed to date.Trial Registrationclinicaltrials.gov Identifier: NCT03035474
       
  • Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS-
           RCT)
    • Abstract: Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): David Birnie, Rob S.B. Beanlands, Pablo Nery, Shawn D. Aaron, Daniel A. Culver, Robert A. DeKemp, Lorne Gula, Andrew Ha, Jeffery S. Healey, Yuko Inoue, Mark A. Judson, Daniel Juneau, Kengo Kusano, Russell Quinn, Lena Rivard, Mustafa Toma, Amanda Varnava, George Wells, Melissa Wickremasinghe, Jordana KronAbstractBackgroundApproximately 5% of patients with sarcoidosis have clinically manifest cardiac involvement. Clinical features of Cardiac Sarcoidosis are dependent on the location, extent, and activity of the disease. First line therapy is usually with prednisone and this is recommended based on clinician experience, expert opinion and small observational cohorts. There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions. Corticosteroid are associated with multiple adverse effects including hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections. In contrast Methotrexate is generally well tolerated and is increasingly used in other forms of sarcoidosis.ObjectivesThe Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT; NCT03593759) is a multicenter randomized controlled trial designed to evaluate the optimal initial treatment strategy for patients with active cardiac sarcoidosis. We hypothesize that (1) a low dose prednisone/methotrexate combination will have non-inferior efficacy to standard dose prednisone and that (2) the low dose prednisone/ methotrexate combination will result in significantly better quality of life than standard dose prednisone, as a result of reduced burden of side effects.Methods/DesignEligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction. Subjects will be randomized in a 1:1 ratio to prednisone 0.5 mg/kg/day for 6 months (maximum dose 30 mg daily) OR to prednisone 20 mg daily for 1 month, then 10 mg daily for 1 month, then 5 mg daily for one month then stop AND methotrexate 15–20 mg once weekly for 6 months. The primary endpoint is summed perfusion rest score on 6-month PET (blinded core-lab review). The summed perfusion rest score is measure of myocardial fibrosis/scar. The design is non-inferiority with a sample size of 97 per group.DiscussionGiven the multiorgan system potential adverse side effects of prednisone, proving noninferiority of an alternate regimen would be sufficient to make the alternative compare favorably to standard dose steroids. This is the first ever clinical trial in cardiac sarcoidosis and thus in addition to the listed goals of the trial, we will also establish a multi-center, multinational cardiac sarcoidosis clinical trials network. Such a collaborative infrastructure will enable a new era of high quality data to guide physicians when treating cardiac sarcoidosis patients.
       
  • Grenada heart project- community health ActioN to EncouraGe healthy
           BEhaviors (GHP–CHANGE): A randomized control peer group based lifestyle
           intervention
    • Abstract: Publication date: Available online 4 September 2019Source: American Heart JournalAuthor(s): Jacqueline Latina, Rodrigo Fernandez-Jimenez, Sameer Bansilal, Samantha Sartori, Rajesh Vedanthan, Marcelle Lewis, Claire Kofler, Marilyn Hunn, Francis Martin, Emilia Bagiella, Michael Farkouh, Valentin FusterAbstractBackgroundThe incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs.AimThe Grenada Heart Project- Community Health ActioN to EncouraGe Healthy BEhaviors (GHP-CHANGE) was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC.MethodsWe recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects.ResultsParticipants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: −0.12 to 0.75; P = .154).ConclusionsThe GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs.
       
  • Clinical research study implementation of case-finding strategies for
           heart failure and chronic obstructive pulmonary disease in the elderly
           with reduced exercise tolerance or dyspnoea: A cluster randomized trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Yvonne van Mourik, Frans H. Rutten, Loes C.M. Bertens, Maarten J.M. Cramer, Jan-Willem J. Lammers, Aisha Gohar, Johannes B. Reitsma, Karel G.M. Moons, Arno W. HoesAbstractBackgroundHeart failure (HF) and chronic obstructive pulmonary disease (COPD) often remain undiagnosed in older individuals, while both disorders inhibit functionality and impair health.AimTo assess the effectiveness of a case-finding strategy of these disorders.Design and settingClustered randomized trial; eighteen general practices from the vicinity of Utrecht, the Netherlands, were randomly allocated to a case-finding strategy or usual care.MethodsMultimorbid community subjects (≥65 years) with dyspnoea or reduced exercise tolerance were eligible for inclusion. The case-finding strategy consisted of history taking, physical examination, blood tests, electrocardiography, spirometry and echocardiography. Subsequent treatment decisions were at the discretion of the general practitioner. Questionnaires regarding health status and functionality were filled out at baseline and after six months of follow-up. Information regarding changes in medication and health care use during the six months follow-up was extracted.Results829 participants were randomized; 389 in the case-finding strategy group and 440 in the usual care group. More patients in the case-finding group received a new diagnosis of HF or COPD than the usual care group (cumulative incidence 34% vs. 2%, and 17% vs. 2%, respectively). Scores for health status, functionality, and health care use were similar between the two strategies after six months of follow-up.ConclusionA case-finding strategy applied in primary care to multimorbid older people with dyspnoea or reduced exercise tolerance resulted in a number of new diagnoses of HF and COPD, but did not result in short-term improvement of health status compared to usual care.Trial registration.ClinicalTrials.gov NCT01148719
       
  • Variations in stepped-wedge cluster randomized trial design: Insights from
           the ‘patient-centered care transitions in heart failure’ trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Rudy R. Unni, Shun Fu Lee, Lehana Thabane, Stuart Connolly, Harriette GC Van SpallAbstractThe stepped-wedge (SW) cluster randomized controlled trial (RCT), in which clusters cross over in a randomized sequence from control to intervention is ideal for the implementation and testing of complex health service interventions. In certain cases, however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required.We examine the logistical and statistical implications of variations in SW design, using the optimization of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) trial for illustration. We review the following complete SW design variations: a typical SW design; a SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested sub-studies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed three incomplete SW design variations in which data is collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness.Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of a SW RCT.
       
 
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