The Food and Drug Administration (FDA) last approved a new oral drug (hydralazine–isosorbide dinitrate) for patients with heart failure and a reduced ejection fraction in 2005 — and this drug was ...recommended only for self-identified black patients who continued to have symptoms despite evidence-based treatment.
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The angiotensin-receptor blocker eplerenone was approved for the treatment of heart failure in 2003. (In 2012, the European Medicines Agency approved ivabradine, which has not received FDA approval.) Now, a novel drug, LCZ696, a dual inhibitor of angiotensin II receptor and neprilysin, may prove to be the first disruptive agent to the heart-failure treatment algorithm, . . .
Purpose Cardiac dysfunction is a serious adverse effect of certain cancer-directed therapies that can interfere with the efficacy of treatment, decrease quality of life, or impact the actual survival ...of the patient with cancer. The purpose of this effort was to develop recommendations for prevention and monitoring of cardiac dysfunction in survivors of adult-onset cancers. Methods Recommendations were developed by an expert panel with multidisciplinary representation using a systematic review (1996 to 2016) of meta-analyses, randomized clinical trials, observational studies, and clinical experience. Study quality was assessed using established methods, per study design. The guideline recommendations were crafted in part using the Guidelines Into Decision Support methodology. Results A total of 104 studies met eligibility criteria and compose the evidentiary basis for the recommendations. The strength of the recommendations in these guidelines is based on the quality, amount, and consistency of the evidence and the balance between benefits and harms. Recommendations It is important for health care providers to initiate the discussion regarding the potential for cardiac dysfunction in individuals in whom the risk is sufficiently high before beginning therapy. Certain higher risk populations of survivors of cancer may benefit from prevention and screening strategies implemented during cancer-directed therapies. Clinical suspicion for cardiac disease should be high and threshold for cardiac evaluation should be low in any survivor who has received potentially cardiotoxic therapy. For certain higher risk survivors of cancer, routine surveillance with cardiac imaging may be warranted after completion of cancer-directed therapy, so that appropriate interventions can be initiated to halt or even reverse the progression of cardiac dysfunction.
Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in ...pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes.
We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly.
A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure ...Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance Technical Panel Steven R. Bailey, MD, FACC, FSCAI, FAHA, Moderator Andrea M. Russo, MD, FACC, FHRS, Writing Group Liaison* Suraj Kapa, MD, Writing Group Liaison Michael B. Alexander, MD, FACC§Health Plan Representative Steven R. Bailey, MD, FACC, FSCAI, FAHA||American College of Cardiology Foundation Representative Ulrika Birgersdotter-Green, MD, FHRS|| Alan S. Brown, MD, FACC, FAHA, FNLA|| Richard A. Grimm, DO, FACC, FASE¶American Society of Echocardiography Representative Paul J. Hauptman, MD#Heart Failure Society of America Representative Sharon A. Hunt, MD, FACC# Rachel Lampert, MD, FACC, FHRS* JoAnn Lindenfeld, MD, FACC**American Heart Association Representative David J. Malenka, MD, FACC|| Kartik Mani, MDdaggerdaggerSociety for Cardiovascular Angiography and Interventions Representative Joseph E. Marine, MD, FACC, FHRS* Edward T. Martin, MD, FACC, FACP, FAHAdouble daggerdouble daggerSociety for Cardiovascular Magnetic Resonance Representative Richard L. Page, MD, FACC, FHRS, FAHA|| Michael W. Rich, MD, FACC§§American Geriatrics Society Representative Paul D. Varosy, MD, FACC, FHRS* Mary Norine Walsh, MD, FACC|| Appropriate Use Criteria Task Force Michael J. Wolk, MD, MACC, Chair Steven R. Bailey, MD, FACC, FSCAI, FAHA John U. Doherty, MD, FACC Pamela S. Douglas, MD, MACC, FAHA Robert C. Hendel, MD, FACC, FAHA, FASNC Christopher M. Kramer, MD, FACC James K. Min, MD, FACC Manesh R. Patel, MD, FACC Leslee Shaw, PhD, FACC, FASNC Raymond F. Stainback, MD, FACC, FASE Joseph M. Allen, MA Table of Contents Abstract... Special Conditions/Comorbidities in Patients for Primary Prevention (Meeting Indications of ICD Implant Related to HF Diagnosis With LVEF <=30% on Guideline-Directed Medical Therapy >3 Months)... .\n Groeneveld None None None None None None Stephen Hammill None None None None None None Charles A. Henrikson None None None Boston Scientific None None Michael Ho None None None None None None Mariell Jessup None None None None None None Stuart D. Katz None None None None None None Bradley P. Knight Boston Scientific Biotronik Boston Scientific Medtronic None None None None Wayne C. Levy None None None None None None Barbara Messinger-Rapport None None None None None None Gerald V. Naccarelli Medtronic None None None None None Robert M. Palmer None None None None None None Samir B. Pancholy None Medtronic None None None None Jeanne E. Poole Biotronik Boston Scientific Medtronic St. Jude Medical None None Medtronic Boston Scientific* Medtronic* St. Jude Medical* None Subha V. Raman None None None None None None Matthew R. Reynolds Medtronic None None None None None William G. Stevenson None None None None None None Cynthia M. Tracy None None None None None None Quynh A. Truong None None None St. Jude Medical* None None Paul J. Wang Boston Scientific Medtronic None None Boston Scientific* Medtronic* None None Bruce L. Wilkoff None None None None Medtronic St. Jude Medical None Appropriate Use Criteria Task Force Michael J. Wolk None None None None None None Steven R. Bailey None None None None None None John U. Doherty None None None None None None Pamela S. Douglas None None None None None None Robert C. Hendel None None None None None None Christopher M. Kramer St. Jude Medical None None None None None James K. Min None None None None None None Manesh R. Patel None None None None None None Leslee Shaw None None None None None None Raymond F. Stainback None None None None None None Joseph M. Allen None None None None None None * This table represents the relevant relationships with industry and other entities that were disclosed by participants at the time of participation. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person's gross income for the previous year.
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