69 results match your criteria: "5 Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School[Affiliation]"

Background: The benefit of implantable cardioverter-defibrillators (ICD) and cardiovascular resynchronization therapy (CRT-D) in patients supported with a HeartMate 3 left ventricular assist device (LVAD) remains uncertain.

Methods: An analysis of the MOMENTUM 3 randomized clinical trial and the first 1000 patients in the Continued Access Protocol trial. Patients were divided into three groups based on the presence of ICD and/or CRT-D: No device (n=153, 11%), ICD only (n=699, 50.

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Background: Left ventricular assist devices (LVADs) are underused among women with advanced heart failure, but reasons remain unclear. Outcomes in women compared with men with contemporary fully magnetically levitated LVADs remain uncertain.

Objectives: The authors examined differences in characteristics, 2-year outcomes, and risk for key adverse events among women and men.

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Article Synopsis
  • The SYMPLICITY HTN-3 trial aimed to evaluate the safety and effectiveness of the Symplicity system for treating patients with uncontrolled hypertension, initially showing safety after 6 months but not efficacy.
  • Conducted across 88 centers in the USA, the trial involved adults aged 18-80 with treatment-resistant hypertension and compared outcomes of renal artery denervation versus a sham control over a follow-up period of 36 months.
  • The final report details long-term blood pressure changes, analyzing results from participants in both the renal denervation group and those who crossed over from the sham group after the 6-month mark.
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Polypill Strategy in Secondary Cardiovascular Prevention.

N Engl J Med

September 2022

From Centro Nacional de Investigaciones Cardiovasculares (J.M.C., S.J.P., A.J.Q., A.F.-O., J.M.F.A., V.A., H.B., J.F.F., B.I., V.F.), Centro Integral de Enfermedades Cardiovasculares, Hospital Universitario Monteprincipe, Grupo HM Hospitales (J.M.C.), Hospital Clínico San Carlos, Universidad Complutense (A.F.-O., D.V.), Centro de Investigacion Biomedica en Red de Enfermedades Cardiovasculares (A.F.-O., P.L.S., F.M.O., J.M.V.R., V.A., H.B., A.C., B.I.), Unidad de Investigación Clínica y Ensayos Clínicos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (A.D.-F.), Health Research Institute, October 12 Hospital (H.B.), Fundación Jiménez Díaz University Hospital (J.F.F., B.I.), and Universidad Autonóma de Madrid (J.F.F.), Madrid, the Department of Cardiology, Hospital Universitario Salamanca, Salamanca (P.L.S.), Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (F.M.O.), Servicio de Cardiología, Hospital Universitario A Coruña, Instituto de Investigación Biomédica A Coruña, La Coruña (J.M.V.R.), Servicio de Cardiología, Hospital Universitario de Cabueñes, Gijón (I.L.), the Cardiovascular Area and Coronary Unit, University Clinical Hospital of Santiago de Compostela, Santiago (M.R.-M.), the Department of Neurology, Hospital Universitario Rey Juan Carlos, Getafe (J.F.F.), and Servicio de Neurología, Hospital General Universitario de Alicante (N.L.), and the Department of Cardiology, Hospital Universitario de San Juan (A.C.), Alicante - all in Spain; the Department of Medical Statistics (S.J.P., R.O., T.C.) and the Centre for Global Chronic Conditions (P. Perel), London School of Hygiene and Tropical Medicine, and Imperial College NHS Trust (A.A.G.), London, and Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool (M.P.) - all in the United Kingdom; Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.) - both in Boston; the Laboratory of Cardiovascular Prevention (M.C.R., M.B., A.F., L.O.-F.) and Laboratorio di Malattie Neurologiche, Dipartimento di Neuroscienze (E.B.), Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, the Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri (M.P.), and the Department of Clinical Sciences and Community Health, University of Milan (M.P.), Milan, and the Clinical and Rehabilitation Cardiology Unit, Emergency Department, San Filippo Neri Hospital, Rome (F.C., S.A.D.F.) - all in Italy; Berlin Institute of Health-Center for Regenerative Therapies, the Department of Internal Medicine and Cardiology (Virchow Klinikum), German Center for Cardiovascular Research, and the Center for Stroke Research Berlin, Charité Universitätsmedizin - all in Berlin (W.D., A.M.); the Department of Cardiology, University Hospital Besançon (F.S., F.E.), and University of Burgundy Franche-Comté (F.S., F.E.), Besançon, the Department of Clinical Pharmacology-Clinical Research Platform, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials, Sorbonne Université, Paris (T.S.), the Department of Neurology, University Hospital of Dijon Burgundy (Y.B.), the Medical School of Dijon, University of Burgundy (Y.B.), and Hôpital François Mitterrand (Y.B.), Dijon - all in France; the 2nd Department of Medicine, Department of Cardiovascular Medicine of the 1st Faculty of Medicine, Charles University, and General University Hospital - both in Prague (A.L., J.-C.L.); Semmelweis Egyetem Városmajori Szív És Érgyógyászati Klinika, Budapest (G.B., B.M.); the Department of Heart Disease, Medical University, Wrocław, Poland (P. Ponikowski, M.K.); the Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium (F.V.W.); the Department of Cardiology, Zealand University Hospital, Roskilde, Denmark (M.M.S.); and the Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (V.F.).

Background: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction.

Methods: In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.

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Coronary artery bypass grafting versus medical therapy in patients with stable coronary artery disease: An individual patient data pooled meta-analysis of randomized trials.

J Thorac Cardiovasc Surg

March 2024

Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY.

Objectives: It is unclear whether coronary artery bypass grafting (CABG) improves survival compared with medical therapy (MT) in patients with stable coronary artery disease (CAD). The aim of this analysis was to perform an individual-patient data-pooled meta-analysis of contemporary randomized controlled trials that compared CABG and MT in patients with stable CAD.

Methods: A systematic search was performed in January 2021 to identify randomized controlled trials enrolling adult patients with stable CAD, randomized to CABG or MT.

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Importance: Current guidelines recommend against use of intravenous alteplase in patients with acute ischemic stroke who are taking non-vitamin K antagonist oral anticoagulants (NOACs).

Objective: To evaluate the safety and functional outcomes of intravenous alteplase among patients who were taking NOACs prior to stroke and compare outcomes with patients who were not taking long-term anticoagulants.

Design, Setting, And Participants: A retrospective cohort study of 163 038 patients with acute ischemic stroke either taking NOACs or not taking anticoagulants prior to stroke and treated with intravenous alteplase within 4.

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Background: The clinical and cost-effectiveness of left ventricular assist device (LVAD) therapy for patients with advanced heart failure (HF) who are ineligible for heart transplantation is debated in the UK. This study develops an indirect comparison between the fully magnetically levitated HeartMate 3 (HM 3) LVAD and medical therapy (MT) to evaluate expected clinical and cost-effectiveness in the UK National Health Service (NHS) context.

Methods: We performed an economic analysis comparing the HM3 pump against the HeartMate II LVAD (MOMENTUM 3), and then another analysis comparing MT with the first- and second-generation HeartMate XVE pump LVAD and HeartMate II LVAD for the same patient population (REMATCH and ROADMAP, respectively).

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Background: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines.

Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010-2013) and Target: Stroke Phase II (2014-2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018.

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Objectives: The authors performed an updated meta-analysis of randomized placebo-controlled trials of renal denervation and specifically compared the effect of renal denervation in patients taking medications and in those not taking medications.

Background: Renal denervation has now undergone several blinded placebo-controlled trials, covering the spectrum from patients with drug-resistant hypertension to those not yet taking antihypertensive medications.

Methods: All blinded placebo-controlled randomized trials of catheter-based renal sympathetic denervation for hypertension were systematically identified, and a random-effects meta-analysis was performed.

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Article Synopsis
  • - The SOLOIST-WHF trial investigated the effects of sotagliflozin, a medication for patients with type 2 diabetes and heart failure, finding it reduced cardiovascular-related events by 33% compared to a placebo.
  • - The study was designed as a randomized, double-blind trial with 1,222 participants across 306 sites in 32 countries, assessing the efficacy of sotagliflozin on outcomes like days alive and out of the hospital (DAOH).
  • - Results showed while hospitalization rates were similar between both groups, those on sotagliflozin experienced fewer repeated hospitalizations and a 3% higher rate of DAOH due to a significant decrease in days lost to death.
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Importance: It is unclear how New York Heart Association (NYHA) functional class compares with patient-reported outcomes among patients with heart failure (HF) in contemporary US clinical practice.

Objective: To characterize longitudinal changes and concordance between NYHA class and the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS), and their associations with clinical outcomes.

Design, Setting, And Participants: This cohort study included 2872 US outpatients with chronic HF with reduced ejection fraction across 145 practices enrolled in the CHAMP-HF registry between December 2015 and October 2017.

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Intensity of statin treatment after acute coronary syndrome, residual risk, and its modification by alirocumab: insights from the ODYSSEY OUTCOMES trial.

Eur J Prev Cardiol

March 2021

Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), and INSERM, France.

Aims: Statins are pivotal to the secondary prevention of major adverse cardiovascular events, but some patients are statin-intolerant. We examined the effects of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab on the risk of major adverse cardiovascular events according to the intensity of background statin treatment.

Methods And Results: The ODYSSEY OUTCOMES trial compared alirocumab with placebo in 18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented).

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Background: Several distinctly engineered left ventricular assist devices (LVADs) are in clinical use. However, contemporaneous real world comparisons have not been conducted, and clinical trials were not powered to evaluate differential survival outcomes across devices.

Objectives: Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs.

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Fine particulate air pollution <2.5 μm in diameter (PM) is a major environmental threat to global public health. Multiple national and international medical and governmental organizations have recognized PM as a risk factor for cardiopulmonary diseases.

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Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i.

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Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.

N Engl J Med

January 2021

From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).

Article Synopsis
  • The study investigated the effects of sotagliflozin, an SGLT2 inhibitor, on patients with type 2 diabetes recently hospitalized for worsening heart failure, comparing it to a placebo.
  • In the trial involving 1222 patients, those on sotagliflozin exhibited a significantly lower rate of hospitalizations and cardiovascular deaths (51.0 events per 100 patient-years) compared to the placebo group (76.3 events per 100 patient-years).
  • Although sotagliflozin was found to be effective, it was associated with higher instances of diarrhea and severe hypoglycemia compared to the placebo, indicating some safety concerns.
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Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.

N Engl J Med

January 2021

From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).

Article Synopsis
  • - The study aimed to assess the effectiveness and safety of sotagliflozin, a sodium-glucose cotransporter 2 inhibitor, in preventing cardiovascular events in patients with type 2 diabetes and chronic kidney disease, though funding issues led to it being ended early.
  • - A total of 10,584 patients were divided equally into two groups—one receiving sotagliflozin and the other a placebo—and monitored for approximately 16 months, focusing on key cardiovascular health outcomes.
  • - Results indicated that the sotagliflozin group experienced fewer primary cardiovascular events (5.6 per 100 patient-years) compared to the placebo group (7.5 per 100 patient-years), but some adverse effects like diarrhea and infections
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Background: Gender disparities in authorship of heart failure (HF) guideline citations and clinical trials have not been examined.

Methods: We identified authors of publications referenced in Class I Recommendations in United States (n=173) and European (n=100) HF guidelines and of publications of all HF trials with >400 participants (n=118) published between 2001 and 2016. Authors' genders were determined, and changes in authorship patterns over time were evaluated with linear regression and nonparametric testing.

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Background: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction.

Objectives: The U.S.

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Background: Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.

Methods: We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19.

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Objectives: The purpose of this study was to characterize the clinical profile, treatment patterns, and clinical outcomes of patients with comorbid diabetes mellitus (DM) and heart failure with reduced ejection fraction (HFrEF) in a contemporary, real-world U.S. outpatient registry in the context of evolving treatment strategies.

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Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.

N Engl J Med

June 2020

From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Surgisphere, Chicago (S.S.D.); Baylor College of Medicine and Department of Veterans Affairs, Houston (S.K.); Christ Hospital, Cincinnati (T.D.H.); the Department of Biomedical Engineering, University of Utah, Salt Lake City (A.N.P.); and HCA Research Institute, Nashville (A.N.P.).

Background: Coronavirus disease 2019 (Covid-19) may disproportionately affect people with cardiovascular disease. Concern has been aroused regarding a potential harmful effect of angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) in this clinical context.

Methods: Using an observational database from 169 hospitals in Asia, Europe, and North America, we evaluated the relationship of cardiovascular disease and drug therapy with in-hospital death among hospitalized patients with Covid-19 who were admitted between December 20, 2019, and March 15, 2020, and were recorded in the Surgical Outcomes Collaborative registry as having either died in the hospital or survived to discharge as of March 28, 2020.

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Background: Mitral regurgitation (MR) determines pathophysiology and outcome in advanced heart failure. The impact of left ventricular assist device (LVAD) placement on clinically significant MR and its contribution to long-term outcomes has been sparsely evaluated.

Methods: We evaluated the effect of clinically significant MR on patients implanted in the MOMENTUM 3 trial with either the HeartMate II (HMII) or the HeartMate 3 (HM3) at 2 years.

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Bariatric surgery improves glycemic control better than medical therapy; however, the effect of bariatric surgery on HDL function is not well characterized. Serum samples were available at baseline, 1-, and 5-years post procedures, for 90 patients with obesity and type 2 diabetes who were randomized to intensive medical therapy ( = 20), Roux-en-Y gastric bypass (RYGB, = 37), or sleeve gastrectomy (SG, = 33) as part of the STAMPEDE clinical trial. We examined serum HDL function by two independent assays, apolipoprotein A-1 exchange rate (AER) and cholesterol efflux capacity (CEC).

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Background: There are limited data on the safety of intravenous recombinant tissue plasminogen activator (rtPA) for treating acute ischemic stroke in patients with gastrointestinal malignancy or recent gastrointestinal bleeding within 21 days of their index stroke.

Aims: To evaluate clinical outcomes in patients treated with rtPA for acute ischemic stroke who had gastrointestinal malignancy or recent gastrointestinal bleeding.

Methods: We identified patients who were treated with rtPA for acute ischemic stroke between 2/2009 and 12/2015 from the Get With The Guidelines-Stroke linked to Medicare claims data.

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