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    Primary percutaneous coronary intervention at centers with and without on-site surgical support: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).
    Am Heart J 2018 Jan 14;195:99-107. Epub 2017 Oct 14.
    Division of Cardiovascular Medicine, Henry Ford Health System, Detroit, MI; Wayne State University, School of Medicine, Detroit, MI. Electronic address:
    Background: Primary percutaneous coronary intervention (PPCI) is being increasingly performed nationally at sites without on-site cardiac surgery; however, recent guidelines only provide a Class IIa recommendation for this practice. The state of Michigan has permitted PPCI without on-site surgery under a closely monitored system that mandates auditing of all procedures and quarterly feedback on quality and outcomes. This study sought to compare outcomes of patients undergoing PPCI at centers with and without on-site surgery in the state of Michigan. Read More

    Role of Doppler echocardiography for cardiac output assessment in Fontan patients.
    Am Heart J 2018 Jan 21;195:91-98. Epub 2017 Sep 21.
    Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.
    Background: To determine (1) correlation between Doppler stroke volume index (SVI) and cardiac magnetic resonance imaging (CMRI) SVI and (2) association between Doppler SVI and Fontan-associated diseases (FAD) and Fontan failure.

    Methods: Review of Fontan patients who underwent same-day CMRI and transthoracic echocardiography (TTE), 2005 to 2015. We defined FAD as cardiac thrombus, protein-losing enteropathy, arrhythmia, and hospitalization for heart failure. Read More

    Chocolate consumption and risk of atrial fibrillation: Two cohort studies and a meta-analysis.
    Am Heart J 2018 Jan 21;195:86-90. Epub 2017 Sep 21.
    Unit of Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
    Background: Chocolate consumption has been inconsistently associated with risk of atrial fibrillation (AF). We investigated the association between chocolate consumption and risk of AF in Swedish adults from two cohort studies and conducted a meta-analysis to summarize available evidence from cohort studies on this topic.

    Methods: Our study population comprised 40,009 men from the Cohort of Swedish Men and 32,486 women from the Swedish Mammography Cohort. Read More

    Efficacy and safety of potent platelet P2Y12 receptor inhibitors in elderly versus nonelderly patients with acute coronary syndrome: A systematic review and meta-analysis.
    Am Heart J 2018 Jan 21;195:78-85. Epub 2017 Sep 21.
    Department of Medicine, Cardiac Catheterization Laboratory, New York Methodist Hospital, New York, NY.
    Background: The use of the potent oral P2Y12 inhibitors prasugrel and ticagrelor in patients with acute coronary syndromes (ACS) has a favorable net clinical effect compared with clopidogrel and is recommended as first-line therapy. However, the impact of these agents on ischemic and bleeding events in elderly ACS patients is not well defined.

    Methods: We performed a systematic review of articles comparing potent P2Y12 inhibitors to clopidogrel in elderly and nonelderly patients (defined according to each study) with ACS in terms of efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (major bleeding) end points. Read More

    Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).
    Am Heart J 2018 Jan 8;195:70-77. Epub 2017 Sep 8.
    Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL. Electronic address:
    Importance: In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials.

    Objective: To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. Read More

    Mineralocorticoid receptor antagonists in patients with acute myocardial infarction - A systematic review and meta-analysis of randomized trials.
    Am Heart J 2018 Jan 15;195:60-69. Epub 2017 Sep 15.
    Population Health Research Institute, McMaster University, Hamilton Health Sciences, 237 Barton St E, Hamilton, Ontario, Canada. Electronic address:
    Background: Although mineralocorticoid antagonists (MRAs) reduce mortality in patients with heart failure complicating myocardial infarction (MI), it is unclear if they could be beneficial to all patients with MI. To evaluate the utility of MRAs in MI patients, we performed a systematic review and meta-analysis.

    Methods: MEDLINE, EMBASE, and Cochrane CENTRAL were searched from 1965 to June 2016. Read More

    Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry.
    Am Heart J 2018 Jan 31;195:50-59. Epub 2017 Aug 31.
    Stanford University School of Medicine (Stanford, CA); VA Palo Alto Health Care System, Palo Alto, CA. Electronic address:
    Background: It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs).

    Methods: We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). Read More

    Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.
    Am Heart J 2018 Jan 8;195:39-49. Epub 2017 Sep 8.
    Division of Cardiology, University of Illinois at Chicago, Chicago, IL. Electronic address:
    Background: We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents.

    Methods: We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. Read More

    The Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A protocol update.
    Am Heart J 2018 Jan 14;195:153-154. Epub 2017 Oct 14.
    University Clinical Center of Serbia, Belgrade, Serbia; Belgrade Medical School, University of Belgrade, Serbia.

    Drug-induced cardiac abnormalities in premature infants and neonates.
    Am Heart J 2018 Jan 31;195:14-38. Epub 2017 Jul 31.
    Bioclinica, Doylestown, PA.
    The Cardiac Safety Research Consortium (CSRC) is a transparent, public-private partnership that was established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University. Our continuing goal is to advance paradigms for more efficient regulatory science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where such safety questions add burden to innovative research and development. This White Paper provides a summary of discussions by a cardiovascular committee cosponsored by the CSRC and the US Food and Drug Administration (FDA) that initially met in December 2014, and periodically convened at FDA's White Oak headquarters from March 2015 to September 2016. Read More

    Design of a bilevel clinical trial targeting adherence in heart failure patients and their providers: The Congestive Heart Failure Adherence Redesign Trial (CHART).
    Am Heart J 2018 Jan 29;195:139-150. Epub 2017 Sep 29.
    Department of Preventive Medicine, Rush University Medical Center, Chicago, IL.
    Background: Socioeconomically disadvantaged patients are at an increased risk for adverse heart failure (HF) outcomes based upon nonadherence to medications and diet. Physicians are also suboptimally adherent to prescribing evidence-based therapy for HF.

    Methods: Congestive Heart Failure Adherence Redesign Trial (CHART) (NCT01698242) is a multicenter, bilevel, cluster randomized behavioral efficacy trial designed to assess the impact of intervening simultaneously on physicians and their socioeconomically disadvantaged patients (annual income <$30,000) having HF with reduced ejection fraction. Read More

    Return to the workforce following infective endocarditis-A nationwide cohort study.
    Am Heart J 2018 Jan 18;195:130-138. Epub 2017 Sep 18.
    Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Background: The ability to return to work after infective endocarditis (IE) holds important socioeconomic consequences for both patients and society, yet data on this issue are sparse. We examined return to the workforce and associated factors in IE patients of working age.

    Methods: Using Danish nationwide registries, we identified 1,065 patients aged 18-60 years with a first-time diagnosis of IE (1996-2013) who were part of the workforce prior to admission and alive at discharge. Read More

    A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.
    Am Heart J 2018 Jan 12;195:115-129. Epub 2017 Sep 12.
    Université Paris-Descartes, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DHU PARC, Paris, France; INSERM, CIC1418, Paris, France.
    Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Read More

    Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.
    Am Heart J 2018 Jan 21;195:108-114. Epub 2017 Sep 21.
    Duke University Medical Center, Durham, NC.
    Background: The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described.

    Methods: BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Read More

    Valve hemodynamic deterioration and cardiovascular outcomes in TAVR: A report from the STS/ACC TVT Registry.
    Am Heart J 2018 Jan 9;195:1-13. Epub 2017 Sep 9.
    Duke Clinical Research Institute, Durham, NC.
    Background: Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes.

    Methods And Results: Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). Read More

    Edoxaban for the management of elderly Japanese patients with atrial fibrillation ineligible for standard oral anticoagulant therapies: Rationale and design of the ELDERCARE-AF study.
    Am Heart J 2017 Dec 24;194:99-106. Epub 2017 Aug 24.
    Cardiovascular Institute, Tokyo, Japan.
    Edoxaban-a non-vitamin K antagonist oral anticoagulant (NOAC)- 60-mg and 30-mg once-daily dose regimens are noninferior versus well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF patients, especially those considered ineligible for available oral anticoagulants. The Edoxaban Low-Dose for EldeR CARE AF patients (ELDERCARE-AF) study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that will compare the safety and efficacy of once-daily edoxaban 15 mg versus placebo in Japanese patients with NVAF ≥80 years of age who are considered ineligible for standard oral anticoagulant therapy. Read More

    Outcomes of cardiac pacing in adult patients after a Fontan operation.
    Am Heart J 2017 Dec 26;194:92-98. Epub 2017 Aug 26.
    Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.
    Background: Cardiac pacing can be challenging after a Fontan operation, and limited data exist regarding pacing in adult Fontan patients. The objectives of our study were to determine risk factors for pacing and occurrence of device-related complications (DRCs) and pacemaker reinterventions.

    Methods: We performed a retrospective review of Fontan patients from 1994 through 2014. Read More

    A unique linkage of administrative and clinical registry databases to expand analytic possibilities in pediatric heart transplantation research.
    Am Heart J 2017 Dec 23;194:9-15. Epub 2017 Aug 23.
    Children's Hospital Association, Lenexa, KS.
    Background: Large clinical, research, and administrative databases are increasingly utilized to facilitate pediatric heart transplant (HTx) research. Linking databases has proven to be a robust strategy across multiple disciplines to expand the possible analyses that can be performed while leveraging the strengths of each dataset. We describe a unique linkage of the Scientific Registry of Transplant Recipients (SRTR) database and the Pediatric Health Information System (PHIS) administrative database to provide a platform to assess resource utilization in pediatric HTx. Read More

    "Bringing on the light" in a complex clinical scenario: Optical coherence tomography-guided discontinuation of antiplatelet therapy in cancer patients with coronary artery disease (PROTECT-OCT registry).
    Am Heart J 2017 Dec 23;194:83-91. Epub 2017 Aug 23.
    University of Missouri, Columbia, MO.
    Background: Cancer patients with recently placed drug-eluting stents (DESs) often require premature dual antiplatelet therapy (DAPT) discontinuation for cancer-related procedures. Optical coherence tomography (OCT) can identify risk factors for stent thrombosis such as stent malapposition, incomplete strut coverage and in-stent restenosis and may help guide discontinuation of DAPT.

    Methods: We conducted a single-center prospective study in cancer patients with recently placed (1-12 months) DES who required premature DAPT discontinuation. Read More

    Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials.
    Am Heart J 2017 Dec 18;194:73-82. Epub 2017 Aug 18.
    St. Antonius Hospital, Department of Cardiology, Nieuwegein, The Netherlands. Electronic address:
    Background: Since older age is a strong predictor of not only bleeding but also of ischemic events, understanding the risk:benefit profile of bivalirudin in the elderly undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation (STEMI) is important. For this, we aim to compare elderly with young patients, who all underwent pPCI for STEMI and randomly received either bivalirudin or heparin.

    Methods: We performed a patient-level pooled analysis (n=5800) of two large randomized trials. Read More

    Predictors of high cost after percutaneous coronary intervention: A review from Japanese multicenter registry overviewing the influence of procedural complications.
    Am Heart J 2017 Dec 18;194:61-72. Epub 2017 Aug 18.
    Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. Electronic address:
    Background: Percutaneous coronary intervention (PCI) is widely used; however, factors of high-cost care after PCI have not been thoroughly investigated. We sought to evaluate the in-hospital costs related to PCI and identify predictors of high costs.

    Methods: We extracted 2,354 consecutive PCI cases (1,243 acute cases, 52. Read More

    Atrial fibrillation decision support tool: Population perspective.
    Am Heart J 2017 Dec 23;194:49-60. Epub 2017 Aug 23.
    Department of Family and Community Medicine, University of Cincinnati, Cincinnati, OH.
    Background: Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients. Read More

    Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial.
    Am Heart J 2017 Dec 12;194:39-48. Epub 2017 Aug 12.
    Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO. Electronic address:
    Background: For patients with severe aortic stenosis (AS) at extreme surgical risk, transcatheter aortic valve replacement (TAVR) leads to improved survival and health status when compared with medical therapy. Whether the early health status benefits of TAVR in these patients are sustained beyond 1 year of follow-up is unknown.

    Methods And Results: Six hundred thirty-nine patients with severe AS at extreme surgical risk underwent TAVR in the CoreValve US Extreme Risk Pivotal trial. Read More

    Contemporary rates and correlates of statin use and adherence in nondiabetic adults with cardiovascular risk factors: The KP CHAMP study.
    Am Heart J 2017 Dec 24;194:25-38. Epub 2017 Aug 24.
    Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Medicine, Kaiser Permanente Oakland Medical Center, Oakland, CA.
    Background: Statin therapy is highly efficacious in the prevention of fatal and nonfatal atherosclerotic events in persons at increased cardiovascular risk. However, its long-term effectiveness in practice depends on a high level of medication adherence by patients.

    Methods: We identified nondiabetic adults with cardiovascular risk factors between 2008 and 2010 within a large integrated health care delivery system in Northern California. Read More

    Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry®-Get With The Guidelines (GWTG)®.
    Am Heart J 2017 Dec 12;194:16-24. Epub 2017 Aug 12.
    Section of Cardiovascular Medicine, Yale University School of Medicine, Center for Outcomes Research and Evaluation, Yale New Haven Health System, New Haven, CT. Electronic address:
    Background: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality.

    Objective: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality.

    Methods: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Read More

    International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries.
    Am Heart J 2017 Dec 24;194:132-140. Epub 2017 Aug 24.
    Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
    Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. We aimed to provide comprehensive data on international patterns of AF stroke prevention treatment.

    Methods: Demographics, comorbidities, and stroke risk of the patients in the GARFIELD-AF (n=51,270), ORBIT-AF I (n=10,132), and ORBIT-AF II (n=11,602) registries were compared (overall N=73,004 from 35 countries). Read More

    Rational and design of a randomized, double-blind, multicenter trial to evaluate the safety and tolerability of furosemide withdrawal in stable chronic outpatients with heart failure: The ReBIC-1 trial.
    Am Heart J 2017 Dec 24;194:125-131. Epub 2017 Aug 24.
    Hospital de Clínicas de Porto Alegre e Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Porto Alegre, (RS), Brazil.
    Aims: Furosemide is commonly prescribed for symptom relief in heart failure (HF) patients. Although few data support the continuous use of loop diuretics in apparently euvolemic HF patients with mild symptoms, there is concern about safety of diuretic withdrawal in these patients. The ReBIC-1 trial was designed to evaluate the safety and tolerability of withdrawing furosemide in stable, euvolemic, chronic HF outpatients. Read More

    Predicting risk of cardiac events among ST-segment elevation myocardial infarction patients with conservatively managed non-infarct-related artery coronary artery disease: An analysis of the Duke Databank for Cardiovascular Disease.
    Am Heart J 2017 Dec 1;194:116-124. Epub 2017 Sep 1.
    Duke Clinical Research Institute, Duke University Health System, Durham, NC, USA. Electronic address:
    Background: Recent randomized evidence has demonstrated benefit with complete revascularization during the index hospitalization for multivessel coronary artery disease ST-segment elevation myocardial infarction (STEMI) patients; however, this benefit likely depends on the risk of future major adverse cardiovascular events (MACE).

    Methods: Using data from Duke University Medical Center (2003-2012), we identified those at high risk for 1-year MACE among 664 STEMI patients with conservatively managed non-infarct-related artery (non-IRA) lesions. Using multivariable logistic regression, we identified clinical and angiographic characteristics associated with MACE (death, myocardial infarction, urgent revascularization) to 1 year and developed an integer-based risk prediction model for clinical use. Read More

    Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.
    Am Heart J 2017 Dec 4;194:107-115. Epub 2017 Sep 4.
    SERM Classic and Established Products, Global Clinical Safety and Pharmacovigilance, Research Triangle Park, NC. Electronic address:
    This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. Read More

    Late outcome of percutaneous mitral commissurotomy: Randomized comparison of Inoue versus double-balloon technique.
    Am Heart J 2017 Dec 18;194:1-8. Epub 2017 Apr 18.
    Divisions of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea. Electronic address:
    Background: Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25 years in a randomized trial.

    Methods: Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double-balloon technique (n = 150; group D). Read More

    Biochemical risk markers and 10-year incidence of atherosclerotic cardiovascular disease: independent predictors, improvement in pooled cohort equation, and risk reclassification.
    Am Heart J 2017 Nov 10;193:95-103. Epub 2017 Aug 10.
    Division of Cardiology, Detroit Medical Center, Wayne State University, Detroit, MI. Electronic address:
    Background: The recommendation for statins in primary atherosclerotic cardiovascular disease (ASCVD) prevention begins with risk estimation using the pooled cohort equation (PCE). However, treatment decisions may still remain uncertain after PCE-based assessment. We therefore developed a simple biomarker score that could supplement decision making. Read More

    Lipid management in contemporary community practice: Results from the Provider Assessment of Lipid Management (PALM) Registry.
    Am Heart J 2017 Nov 12;193:84-92. Epub 2017 Aug 12.
    Duke Clinical Research Institute, Durham, NC.
    Background: The latest cholesterol guidelines have shifted focus from achieving low-density lipoprotein cholesterol (LDL-C) targets toward statin use and intensity guided by atherosclerotic cardiovascular disease (ASCVD) risk.

    Methods: Statin use and intensity were evaluated in 5,905 statin-eligible primary or secondary prevention patients from 138 PALM Registry practices.

    Results: Overall, 74. Read More

    Comparison of prevalence and management of left atrial appendage thrombi under old and new anticoagulants prior to left atrial catheter ablation.
    Am Heart J 2017 Nov 2;193:8-15. Epub 2017 Aug 2.
    Division of Cardiology, Jean Monnet University (ADC, CD, JBG, AG, RP, CRB, and KI), Saint-Etienne, France.
    Background: The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation.

    Methods: Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2. Read More

    Long-term outcomes of bypass grafting versus drug-eluting stenting for left main coronary artery disease: Results from the IRIS-MAIN registry.
    Am Heart J 2017 Nov 10;193:76-83. Epub 2017 Aug 10.
    Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
    There are limited data on comparative outcomes and its determinants following coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for left main coronary artery disease (LMCAD) in a real-world setting.

    Methods: A total of 3,504 consecutive patients with LMCAD treated with CABG (n=1,301) or PCI with DES (n=2,203) from the IRIS-MAIN registry were analyzed. The relative treatment effect of one strategy over another was assessed by propensity-score matching method. Read More

    Temporal changes in infective endocarditis guidelines during the last 12 years: High-level evidence needed.
    Am Heart J 2017 Nov 2;193:70-75. Epub 2017 Aug 2.
    Heart Centre, Rigshospitalet, Copenhagen, Denmark.
    Background: Infective endocarditis (IE) is a complex disease necessitating extensive clinical guidelines. The guidelines from the American Heart Association (AHA) and the European Society of Cardiology (ESC) have been markedly extended during the last 12 years. We examined the evidence base for these changes. Read More

    Instantaneous wave-free ratio and fractional flow reserve for the assessment of nonculprit lesions during the index procedure in patients with ST-segment elevation myocardial infarction: The WAVE study.
    Am Heart J 2017 Nov 3;193:63-69. Epub 2017 Aug 3.
    Interventional Cardiology Unit-San Camillo Hospital, Rome.
    Background: Functional assessment of non-infarct-related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting.

    Methods: In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5-8 days after). Read More

    Regional variation in quality of life in patients with a Fontan circulation: A multinational perspective.
    Am Heart J 2017 Nov 2;193:55-62. Epub 2017 Aug 2.
    Cincinnati Children's Hospital Medical Center, Cincinnati, OH. Electronic address:
    Background: Impaired quality of life (QOL) is associated with congenital heart disease (CHD) and country of residence; however, few studies have compared QOL in patients with differing complexities of CHD across regional populations. The current study examined regional variation in QOL outcomes in a large multinational sample of patients with a Fontan relative to patients with atrial septal defects (ASDs) and ventricular septal defects (VSDs).

    Methods: From the Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease-International Study (APPROACH-IS), 405 patients (163 Fontan and 242 ASD/VSD) across Asia, Europe, and North America provided consent for access to their medical records and completed a survey evaluating QOL (0 to 100 linear analog scale). Read More

    Does renal function affect the efficacy or safety of a pharmacoinvasive strategy in patients with ST-elevation myocardial infarction? A meta-analysis.
    Am Heart J 2017 Nov 2;193:46-54. Epub 2017 Aug 2.
    Terrence Donnelly Heart Centre, Michael's Hospital, Toronto, Ontario; University of Toronto, Toronto, Ontario. Electronic address:
    Background: The efficacy and safety of pharmacoinvasive strategy following fibrinolysis for ST-elevation myocardial infarction (STEMI) in relation to renal function have not been established.

    Methods: Using patient-level data from 4 randomized controlled trials, we examined the efficacy and safety of pharmacoinvasive versus standard treatment after fibrinolysis for STEMI. Patients were stratified based on the estimated glomerular filtration rate (eGFR) on presentation (<60 mL/min/1. Read More

    Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.
    Am Heart J 2017 Nov 5;193:35-45. Epub 2017 Aug 5.
    Baim Institute for Clinical Research, Boston, MA; Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA. Electronic address:
    Background: Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. Read More

    Design for the sacubitril/valsartan (LCZ696) compared with enalapril study of pediatric patients with heart failure due to systemic left ventricle systolic dysfunction (PANORAMA-HF study).
    Am Heart J 2017 Nov 17;193:23-34. Epub 2017 Jul 17.
    Novartis Pharmaceuticals Corporation, Shanghai, China. Electronic address:
    Background: Sacubitril/valsartan (LCZ696) is an angiotensin receptor neprilysin inhibitor approved for the treatment of adult heart failure (HF); however, the benefit of sacubitril/valsartan in pediatric HF patients is unknown.

    Study Design: This global multi-center study will use an adaptive, seamless two-part design. Part 1 will assess the pharmacokinetics/pharmacodynamics of single ascending doses of sacubitril/valsartan in pediatric (1 month to <18 years) HF patients with systemic left ventricle and reduced left ventricular systolic function stratified into 3 age groups (Group 1: 6 to <18 years; Group 2: 1 to <6 years; Group 3: 1 month to <1 year). Read More

    The relationship of renal function to outcome: A post hoc analysis from the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study.
    Am Heart J 2017 Nov 20;193:16-22. Epub 2017 Jul 20.
    St. Vincenz-Hospital, Paderborn, Am Busdorf 2, Paderborn, Nordrhein-Westfalen, Germany, and Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany.
    The ENSURE-AF study (NCT 02072434) of anticoagulation for electrical cardioversion in nonvalvular atrial fibrillation (NVAF) showed comparable low rates of bleeding and thromboembolism between the edoxaban and the enoxaparin-warfarin treatment arms. This post hoc analysis investigated the relationship between renal function and clinical outcomes.

    Methods: ENSURE-AF was a multicenter, PROBE evaluation trial of edoxaban 60 mg, or dose reduced to 30 mg/d for weight≤60 kg, creatinine clearance (CrCl; Cockcroft-Gault) ≤50 mL/min, or concomitant P-glycoprotein inhibitors compared with therapeutically monitored enoxaparin-warfarin in 2,199 NVAF patients undergoing electrical cardioversion. Read More

    Temporal trends and hospital-level variation of inhospital cardiac arrest incidence and outcomes in the Veterans Health Administration.
    Am Heart J 2017 Nov 7;193:117-123. Epub 2017 Aug 7.
    VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI; University of Michigan Medical School, Ann Arbor, MI.
    Background: Despite significant attention to resuscitation care by hospitals, national data on trends in the incidence and survival of patients with inhospital cardiac arrest (IHCA) are limited.

    Objective: To determine trends and hospital-level variation in the incidence and outcomes associated with IHCA. In exploratory analyses, we evaluated the relationship between hospital-level IHCA incidence and outcomes with general hospital-wide quality improvement activities. Read More

    Association between hospital rates of early Do-Not-Resuscitate orders and favorable neurological survival among survivors of inhospital cardiac arrest.
    Am Heart J 2017 Nov 7;193:108-116. Epub 2017 Aug 7.
    Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, MO.
    Background: Current guidelines recommend deferring prognostication for 48 to 72 hours after resuscitation from inhospital cardiac arrest. It is unknown whether hospitals vary in making patients who survive an arrest Do-Not-Resuscitate (DNR) early after resuscitation and whether a hospital's rate of early DNR is associated with its rate of favorable neurological survival.

    Methods: Within Get With the Guidelines-Resuscitation, we identified 24,899 patients from 236 hospitals who achieved return of spontaneous circulation (ROSC) after inhospital cardiac arrest between 2006 and 2012. Read More

    Association between influenza vaccination and reduced risks of major adverse cardiovascular events in elderly patients.
    Am Heart J 2017 Nov 2;193:1-7. Epub 2017 Aug 2.
    Graduate Institute of Life Sciences, National Defense Medical Center, Taipei, Taiwan; Division of Infectious Diseases, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
    Background: This study was conducted to determine the protective effect of influenza vaccine against primary major adverse cardiovascular events (MACEs) in elderly patients, especially those with influenza-like illness (ILI).

    Methods: This retrospective, population-based case-control study of an elderly population (age≥65 years) was conducted using Taiwan's National Health Insurance Research Database (2000-2013). One control was selected for each MACE case (n=80,363 each), matched according to age, year of study entry, and predisposing factors for MACEs. Read More

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