Background: There is a paucity of information on patients hospitalized with heart failure (HF) who leave against medical advice (AMA). We sought to identify patient and hospital characteristics and outcomes of patients with HF who left AMA compared with those conventionally discharged to home. Methods and Results: Using the Get With The Guidelines-Heart Failure registry, data were analyzed from January 2010 to June 2019. In addition, outcomes were examined from a subset of hospitalizations with Medicare-linked claims between January 2010 and November 2015. The fully eligible population included 561,823 patients and the Medicare-linked subset included 74,502 patients. In total, 8747 patients (1.56%) left AMA. The proportion of patients leaving AMA increased from 1.1% to 2.1% over the years of study. Patients leaving a HF hospitalization AMA, compared with patients conventionally discharged to home, were more likely younger, minorities, Medicaid covered, or uninsured. The Medicare-linked subset of patients who left AMA had substantially higher 30-day and 12-month readmission rates and higher mortality at each assessment point over 12 months compared with patients who were conventionally discharged to home. After risk adjustments, the hazard ratio of mortality in the Medicare-linked subset AMA group compared with the conventionally discharged to home group was 1.25 (95% confidence interval, 1.03-1.51; P=.005). Conclusions: One in 64 hospitalized patients with HF left AMA. An AMA discharge status was associated with higher risk for adverse 30-day and 12-month outcomes compared with being conventionally discharged home. Strategies that identify patients at risk of leaving AMA and policies to direct interventional strategies are warranted.

There is a paucity of data on the patients [pts] with heart failure (HF) who leave against medical advice (AMA). We sought to identify pts and hospital characteristics and outcomes of hospitalized pts with HF who left AMA compared to pts discharged home. Data from Get With The Guidelines-HF from

Introduction: A notable portion of the excess burden of cardiovascular disease [CVD] risk factors in African Americans [AA] is believed secondary to the diet. Hypothesis: Dietary assessment and prescribed diets are inadequate in patients admitted to the coronary care unit [CCU]. Results: Cohort: 267 consecutively patients, AA 83%, male 55%, mean age 65 yrs, were assessed for cardiovascular [CV] risk factors, clinical status and appropriateness of prescribed diets. Patients were at increased CV risk as evidenced by 65% older than 60 yrs, Body Mass Index (BMI) >30 in 40% with women almost twice as likely to be obese [p<0.006], history of smoking 55%, hypertension 90%, diabetes 54%, and mean ejection fraction 43%. Established CAD acknowledged in 60%. Breakdown of diet orders: normal diet 11%, diabetic diet 38% and a form of low sodium, low cholesterol diet in 51%. CCU length of stay: 2.5 days with no significant difference by sex, diabetic or obesity status. Dietary assessment documentation was missing in 40% of the CCU admissions. A significant percentage of the patients missing this documentation were women [45%], diabetics [47%], obese--BMI>30 [42%] and older--age >60 [68%]. Incongruence is seen between the disease burden and the appropriate dietary order. For example, 54% of patients had DM. However, only 38% were given a diabetic diet. A form of low Na diet was provided to 51% of the patients yet 90% of them were hypertensive or had a history of hypertension. The statistic, dietary assessment not recorded in 40% of the patients, may have been affected by the relatively short CCU stay. One limitation of our study is that we did not examine if this decreased dietary assessment rate was affected by week-day vs. weekend stay in the CCU or by the severity of the patient’s illness. Conclusion: Dietary assessment and appropriate dietary prescription matters. Recent studies show that dietary pattern is one of the largest mediating factors for differences in the incidence of CV risks, i.e. hypertension, in blacks vs. whites accounting for some of the excess risk among blacks. Not adequately addressing nutrition in a CCU setting leads to the loss of a critical teachable moment.

Growth Differentiation Factor-15 (GDF-15) is elevated and prognostic in CAD. Sparse data is available on potential mechanism or its activity in minority populations. Methods: Cohort: 80 patients with AF and ACS. Standard labs, EKG, and echo were performed along with coronary angiography and

Introduction: The blunting of the expected improvement in cardiovascular health over the past decade has been attributed in part to the substantial increase in the prevalence of obesity. Atrial fibrillation and heart failure are among the cardiovascular diseases with increasing incidence in the US. We sought to evaluate the effect of obesity on the predicted 6-month mortality in our patients with atrial fibrillation [AF] and acute coronary syndrome [ACS] utilizing the GRACE score [GS], a validated risk assessment model for predicting death within 6-months of hospital discharge. Methods: Eighty patients, 88% black, 54% female, mean age 68, +/-12, h/o AF admitted with ACS were included. Results: An extraordinarily high prevalence of DM and HTN [46% and 95% respectively] and obesity [46%] were noted. The mean weight: 87 Kg, +/- 23. The mean BMI was 31 kgm 2 , +/-10; median BMI 29 kgm 2 and 25% had a BMI of 35 kgm 2 or greater, (Chart). Seventy-five percent of the cohort had clinical or radiographic evidence of congestion. Ejection fraction: mean 45%, +/-17. B-type natriuretic peptide [BNP] level: mean 765 pg/ml. BNP was significantly and negatively related to obesity [BMI p= 0.0001; r= - 0.422; weight p= 0.001; r= - .359]. This inverse relationship of BNP and obesity was most apparent when comparing the level of BNP in patients who were at or above the median BMI (29.3 kgm 2 ), p= 0.001, (Fig). Although we found a significant direct association of the GS with age [p<0.001; r= .62], troponin [p=0.001; r= .74] and BNP [p= 0.018; r= .41], no independent significant relationship was apparent with obesity [weight p= 0.54; r= -.11, or BMI p= 0.11; r= -.28]. Conclusions: In a traditionally high risk cohort with AF and ACS a high prevalence of obesity was recorded. Clinical or radiographic evidence of congestion was present in the majority. We found no significant link between obesity in this population and the GS—predictor of 6-month mortality. Can this be another cardiovascular paradox? Lengthier outcome studies of larger cohorts are warranted.

Self-care is defined as a naturalistic decision-making process addressing both the prevention and management of chronic illness, with core elements of self-care maintenance, self-care monitoring, and self-care management. In this scientific statement, we describe the importance of self-care in the American Heart Association mission and vision of building healthier lives, free of cardiovascular diseases and stroke. The evidence supporting specific self-care behaviors such as diet and exercise, barriers to self-care, and the effectiveness of self-care in improving outcomes is reviewed, as is the evidence supporting various individual, family-based, and community-based approaches to improving self-care. Although there are many nuances to the relationships between self-care and outcomes, there is strong evidence that self-care is effective in achieving the goals of the treatment plan and cannot be ignored. As such, greater emphasis should be placed on self-care in evidence-based guidelines.

Mechanical circulatory support (MCS) offers a surgical option for advanced heart failure when optimal medical therapy is inadequate. MCS therapy improves prognosis, functional status, and quality of life. 1,2 The INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) tracks patient selection and outcomes for all implanted US Food and Drug Administration-approved MCS devices. From June 2006 until December 2014, >15 000 patients received MCS, and >2000 implantations are performed annually. One-year survival with current continuous-flow devices is reported to be 80%, and 2-year survival, 70%.(3) In patients awaiting heart transplantation, MCS provides a bridge to transplantation, and for others who are ineligible for heart transplantation, MCS provides permanent support or destination therapy. Indications and absolute and relative contraindications to durable MCS are listed in Table 1.As of July 2014, 158 centers in the United States offer long-term MCS. 3 Patients often live a substantial distance from the implanting center, necessitating active involvement of local first responders (emergency medical technicians, police, and fire department personnel), emergency department staff, primary care, and referring cardiologists. Because patients with MCS are becoming increasingly mobile, basic knowledge of equipment is necessary for personnel in public areas such as schools, public transportation, and airplanes/airports. Ambulatory patients with MCS can span the entire age spectrum from pediatrics to geriatrics. The aim of this document is to provide guidance for nonexperts in MCS and to facilitate the informed assessment, stabilization, and transport of the patient with MCS back to the MCS center for definitive therapy. In addition, the principles herein provide a foundation for emergency management and a framework to address the management of known MCS-associated complications and expected comorbid medical problems.

Introduction: Renal dysfunction, an independent risk factor for cardiovascular [CV] morbidity and mortality, has a higher prevalence in black patients. Along the spectrum of cardiovascular diseases...

The composition of the population according to race/ethnicity is changing. In 2014 the proportions of non-Hispanic white and minority populations were 62% and 38%, respectively. Projected change of the racial and ethnic diversity for 2060 is: non-Hispanic whites 44%, minorities 56% [(1)][1]. A

Hypothyroidism is a risk factor of heart failure (HF) in the general population. However, the relationship between hypothyroidism and clinical outcomes in patients with established HF is still inconclusive.We conducted a systematic review and meta-analysis to clarify the association of hypothyroidism and all-cause mortality as well as cardiac death and/or hospitalization in patients with HF. We searched MEDLINE via PubMed, EMBASE, and Scopus databases for studies of hypothyroidism and clinical outcomes in patients with HF published up to the end of January 2015. Random-effects models were used to estimate summary relative risk (RR) statistics. We included 13 articles that reported RR estimates and 95% confidence intervals (95% CIs) for hypothyroidism with outcomes in patients with HF. For the association of hypothyroidism with all-cause mortality and with cardiac death and/or hospitalization, the pooled RR was 1.44 (95% CI: 1.29-1.61) and 1.37 (95% CI: 1.22-1.55), respectively. However, the association disappeared on adjustment for B-type natriuretic protein level (RR 1.17, 95% CI: 0.90-1.52) and in studies of patients with mean age <65 years (RR 1.23, 95% CI: 0.88-1.76).We found hypothyroidism associated with increased all-cause mortality as well as cardiac death and/or hospitalization in patients with HF. Further diagnostic and therapeutic procedures for hypothyroidism may be needed for patients with HF.

WRITING COMMITTEE MEMBERS* Clyde W. Yancy, MD, MSc, FACC, FAHA, Chairyz; Mariell Jessup, MD, FACC, FAHA, Vice Chair*y; Biykem Bozkurt, MD, PhD, FACC, FAHAy; Javed Butler, MBBS, FACC, FAHA*y; Donald E. Casey, Jr, MD, MPH, MBA, FACP, FAHAx; Mark H. Drazner, MD, MSc, FACC, FAHA*y; Gregg C. Fonarow, MD, FACC, FAHA*y; Stephen A. Geraci, MD, FACC, FAHA, FCCPjj; Tamara Horwich, MD, FACCy; James L. Januzzi, MD, FACC*y; Maryl R. Johnson, MD, FACC, FAHA{; Edward K. Kasper, MD, FACC, FAHAy; Wayne C. Levy, MD, FACC*y; Frederick A. Masoudi, MD, MSPH, FACC, FAHAy#; Patrick E. McBride, MD, MPH, FACC**; John J. V. McMurray, MD, FACC*y; Judith E. Mitchell, MD, FACC, FAHAy; Pamela N. Peterson, MD, MSPH, FACC, FAHAy; Barbara Riegel, DNSc, RN, FAHAy; Flora Sam, MD, FACC, FAHAy; Lynne W. Stevenson, MD, FACC*y; W. H. Wilson Tang, MD, FACC*y; Emily J. Tsai, MD, FACCy; Bruce L. Wilkoff, MD, FACC, FHRS*yy

Objectives The aim of this study was to investigate whether patients with systolic heart failure (HF) and abnormal thyroid function are at increased risk for death.Background Thyroid hormone homeostasis is vital to the optimal functioning of the cardiovascular system, but an independent prognostic effect of thyroid abnormalities in patients with HF has not been established.Methods In SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), which randomized patients with ischemic or nonischemic HF to placebo or amiodarone or implantable cardioverter-defibrillator therapy, thyroid-stimulating hormone (TSH) was measured at baseline and at 6-month intervals throughout the 5-year study.Results Of 2,225 patients, the majority (87%) had normal TSH levels (0.3 to 5.0 mU/ml) at baseline, 12% had values suggestive of hypothyroidism, and 1% had values consistent with hyperthyroidism. Compared with euthyroid patients, those hypothyroid at baseline were older and included more women and Caucasians (all p values <0.05). Over the median follow-up period of 45.5 months, among patients euthyroid at baseline, 89 developed abnormally low TSH levels, and 341 developed abnormally high values. Patients randomized to amiodarone (median dose 300 mg) had an elevated risk for developing abnormal TSH levels compared with implantable cardioverter-defibrillator therapy or placebo (p < 0.0001). Patients with baseline or new-onset abnormal thyroid function had a higher mortality than those with normal thyroid function, even after controlling for other known mortality predictors (hazard ratio: 1.58; 95% confidence interval: 1.29 to 1.94; p < 0.0001 for hypothyroid; hazard ratio: 1.85; 95% confidence interval: 1.21 to 2.83; p = 0.0048 for hyperthyroid). Implantable cardioverter-defibrillator benefit did not vary with thyroid function.Conclusions Abnormal thyroid function in patients with symptomatic HF and ejection fractions <= 35% is associated with significantly increased risk for death, even after controlling for known mortality predictors. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609) (C) 2013 by the American College of Cardiology Foundation

Obstructive sleep apnea (OSA) has emerged as a new and important risk factor for cardiovascular disease (CVD). Over the last decade, epidemiologic and clinical research has consistently supported the association of OSA with increased cardiovascular (CV) morbidity and mortality. Such evidence prompted the American Heart Association to issue a scientific statement describing the need to recognize OSA as an important target for therapy in reducing CV risk. Emerging facts suggest that marked racial differences exist in the association of OSA with CVD. Although both conditions are more prevalent in blacks, almost all National Institutes of Health-funded research projects evaluating the relationship between OSA and CV risk have been conducted in predominantly white populations. There is an urgent need for research studies investigating the CV impact of OSA among high-risk minorities, especially blacks. This article first examines the evidence supporting the association between OSA and CVD and reviews the influence of ethnic/racial differences on this association. Public health implications of OSA and future directions, especially regarding minority populations, are discussed.

*Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply; see Appendix 1 for recusal information.†ACCF/AHA representative.‡ACCF/AHA Task Force on Practice Guidelines liaison.§American College of Physicians representative.‖American College of Chest Physicians representative.¶International Society for Heart and Lung Transplantation representative.#ACCF/AHA Task Force on Performance Measures liaison.**American Academy of Family Physicians representative.††Heart Rhythm Society representative.‡‡Former Task Force member during this writing effort.Full-text guideline available at: http://circ.ahajournals.org/lookup/doi/10.1161/CIR.0b013e31829e8776.This document was approved by the American College of Cardiology Foundation Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in May 2013.

Jeffrey L. Anderson, MD, FACC, FAHA, Chair; Alice K. Jacobs, MD, FACC, FAHA, Immediate Past Chair[‡‡][1]; Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN, FAHA; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC; Mark A. Creager, MD, FACC,

HomeCirculationVol. 128, No. 162013 ACCF/AHA Guideline for the Management of Heart Failure Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUB2013 ACCF/AHA Guideline for the Management of Heart FailureA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines , Clyde W. Yancy, MD, MSc, FACC, FAHA, Chair, Mariell Jessup, MD, FACC, FAHA, Vice Chair, Biykem Bozkurt, MD, PhD, FACC, FAHA, Javed Butler, MBBS, FACC, FAHA, Donald E. CaseyJr, MD, MPH, MBA, FACP, FAHA, Mark H. Drazner, MD, MSc, FACC, FAHA, Gregg C. Fonarow, MD, FACC, FAHA, Stephen A. Geraci, MD, FACC, FAHA, FCCP, Tamara Horwich, MD, FACC, James L. Januzzi, MD, FACC, Maryl R. Johnson, MD, FACC, FAHA, Edward K. Kasper, MD, FACC, FAHA, Wayne C. Levy, MD, FACC, Frederick A. Masoudi, MD, MSPH, FACC, FAHA, Patrick E. McBride, MD, MPH, FACC, John J.V. McMurray, MD, FACC, Judith E. Mitchell, MD, FACC, FAHA, Pamela N. Peterson, MD, MSPH, FACC, FAHA, Barbara Riegel, DNSc, RN, FAHA, Flora Sam, MD, FACC, FAHA, Lynne W. Stevenson, MD, FACC, W.H. Wilson Tang, MD, FACC, Emily J. Tsai, MD, FACC and Bruce L. Wilkoff, MD, FACC, FHRS Search for more papers by this author , Clyde W. YancyClyde W. Yancy Search for more papers by this author , Mariell JessupMariell Jessup Search for more papers by this author , Biykem BozkurtBiykem Bozkurt Search for more papers by this author , Javed ButlerJaved Butler Search for more papers by this author , Donald E. CaseyJrDonald E. CaseyJr Search for more papers by this author , Mark H. DraznerMark H. Drazner Search for more papers by this author , Gregg C. FonarowGregg C. Fonarow Search for more papers by this author , Stephen A. GeraciStephen A. Geraci Search for more papers by this author , Tamara HorwichTamara Horwich Search for more papers by this author , James L. JanuzziJames L. Januzzi Search for more papers by this author , Maryl R. JohnsonMaryl R. Johnson Search for more papers by this author , Edward K. KasperEdward K. Kasper Search for more papers by this author , Wayne C. LevyWayne C. Levy Search for more papers by this author , Frederick A. MasoudiFrederick A. Masoudi Search for more papers by this author , Patrick E. McBridePatrick E. McBride Search for more papers by this author , John J.V. McMurrayJohn J.V. McMurray Search for more papers by this author , Judith E. MitchellJudith E. Mitchell Search for more papers by this author , Pamela N. PetersonPamela N. Peterson Search for more papers by this author , Barbara RiegelBarbara Riegel Search for more papers by this author , Flora SamFlora Sam Search for more papers by this author , Lynne W. StevensonLynne W. Stevenson Search for more papers by this author , W.H. Wilson TangW.H. Wilson Tang Search for more papers by this author , Emily J. TsaiEmily J. Tsai Search for more papers by this author and Bruce L. WilkoffBruce L. Wilkoff Search for more papers by this author and WRITING COMMITTEE MEMBERS Originally published5 Jun 2013https://doi.org/10.1161/CIR.0b013e31829e8776Circulation. 2013;128:e240–e327Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2013: Previous Version 1 Table of ContentsPreamble e2421. Introduction e2451.1. Methodology and Evidence Review e2451.2. Organization of the Writing Committee e2451.3. Document Review and Approval e2451.4. Scope of This Guideline With Reference to Other Relevant Guidelines or Statements e2452. Definition of HF e2462.1. HF With Reduced EF (HFrEF) e2472.2. HF With Preserved EF (HFpEF) e2473. HF Classifications e2474. Epidemiology e2484.1. Mortality e2484.2. Hospitalizations e2484.3. Asymptomatic LV Dysfunction e2484.4. Health-Related Quality of Life and Functional Status e2494.5. Economic Burden of HF e2494.6. Important Risk Factors for HF (Hypertension, Diabetes Mellitus, Metabolic Syndrome, and Atherosclerotic Disease) e2495. Cardiac Structural Abnormalities and Other Causes of HF e2495.1. Dilated Cardiomyopathies e2495.1.1. Definition and Classification of Dilated Cardiomyopathies e2495.1.2. Epidemiology and Natural History of DCM e2505.2. Familial Cardiomyopathies e2505.3. Endocrine and Metabolic Causes of Cardiomyopathy e2505.3.1. Obesity e2505.3.2. Diabetic Cardiomyopathy e2505.3.3. Thyroid Disease e2505.3.4. Acromegaly and Growth Hormone Deficiency e2505.4. Toxic Cardiomyopathy e2515.4.1. Alcoholic Cardiomyopathy e2515.4.2. Cocaine Cardiomyopathy e2515.4.3. Cardiotoxicity Related to Cancer Therapies e2515.4.4. Other Myocardial Toxins and Nutritional Causes of Cardiomyopathy e2515.5. Tachycardia-Induced Cardiomyopathy e2515.6. Myocarditis and Cardiomyopathies Due to Inflammation e2515.6.1. Myocarditis e2515.6.2. Acquired Immunodeficiency Syndrome e2525.6.3. Chagas Disease e2525.7. Inflammation-Induced Cardiomyopathy: Noninfectious Causes e2525.7.1. Hypersensitivity Myocarditis e2525.7.2. Rheumatological/Connective Tissue Disorders e2525.8. Peripartum Cardiomyopathy e2525.9. Cardiomyopathy Caused By Iron Overload e2525.10. Amyloidosis e2525.11. Cardiac Sarcoidosis e2535.12. Stress (Takotsubo) Cardiomyopathy e2536. Initial and Serial Evaluation of the HF Patient e2536.1. Clinical Evaluation e2536.1.1. History and Physical Examination: Recommendations e2536.1.2. Risk Scoring: Recommendation e2536.2. Diagnostic Tests: Recommendations e2536.3. Biomarkers: Recommendations e2556.3.1. Natriuretic Peptides: BNP or NT-proBNP e2566.3.2. Biomarkers of Myocardial Injury: Cardiac Troponin T or I e2566.3.3. Other Emerging Biomarkers e2566.4. Noninvasive Cardiac Imaging: Recommendations e2566.5. Invasive Evaluation: Recommendations e2586.5.1. Right-Heart Catheterization e2596.5.2. Left-Heart Catheterization e2596.5.3. Endomyocardial Biopsy e2607. Treatment of Stages A to D e2607.1. Stage A: Recommendations e2607.1.1. Recognition and Treatment of Elevated Blood Pressure e2607.1.2. Treatment of Dyslipidemia and Vascular Risk e2607.1.3. Obesity and Diabetes Mellitus e2607.1.4. Recognition and Control of Other Conditions That May Lead to HF e2607.2. Stage B: Recommendations e2617.2.1. Management Strategies for Stage B e2627.3. Stage C e2627.3.1. Nonpharmacological Interventions e2627.3.1.1. Education: Recommendation e2627.3.1.2. Social Support e2637.3.1.3. Sodium Restriction: Recommendation e2637.3.1.4. Treatment of Sleep Disorders: Recommendation e2637.3.1.5. Weight Loss e2637.3.1.6. Activity, Exercise Prescription, and Cardiac Rehabilitation: Recommendations e2647.3.2. Pharmacological Treatment for Stage C HFrEF: Recommendations e2647.3.2.1. Diuretics: Recommendation e2657.3.2.2. ACE Inhibitors: Recommendation e2657.3.2.3. ARBs: Recommendations e2677.3.2.4. Beta Blockers: Recommendation e2677.3.2.5. Aldosterone Receptor Antagonists: Recommendations e2687.3.2.6. Hydralazine and Isosorbide Dinitrate: Recommendations e2707.3.2.7. Digoxin: Recommendation e2717.3.2.8. Other Drug Treatment e2717.3.2.8.1. Anticoagulation: Recommendations e2717.3.2.8.2. Statins: Recommendation e2727.3.2.8.3. Omega-3 Fatty Acids: Recommendation e2727.3.2.9. Drugs of Unproven Value or That May Worsen HF: Recommendations e2737.3.2.9.1. Nutritional Supplements and Hormonal Therapies e2737.3.2.9.2. Antiarrhythmic Agents e2737.3.2.9.3. Calcium Channel Blockers: Recommendation e2737.3.2.9.4. Nonsteroidal Anti-Inflammatory Drugs e2747.3.2.9.5. Thiazolidinediones e2747.3.3. Pharmacological Treatment for Stage C HFpEF: Recommendations e2747.3.4. Device Therapy for Stage C HFrEF: Recommendations e2747.3.4.1. Implantable Cardioverter-Defibrillator e2787.3.4.2. Cardiac Resynchronization Therapy e2797.4. Stage D e2807.4.1. Definition of Advanced HF e2807.4.2. Important Considerations in Determining If the Patient Is Refractory e2807.4.3. Water Restriction: Recommendation e2807.4.4. Inotropic Support: Recommendations e2817.4.5. Mechanical Circulatory Support: Recommendations e2827.4.6. Cardiac Transplantation: Recommendation e2838. The Hospitalized Patient e2848.1. Classification of Acute Decompensated HF e2848.2. Precipitating Causes of Decompensated HF: Recommendations e2858.3. Maintenance of GDMT During Hospitalization: Recommendations e2868.4. Diuretics in Hospitalized Patients: Recommendations e2868.5. Renal Replacement Therapy—Ultrafiltration: Recommendations e2878.6. Parenteral Therapy in Hospitalized HF: Recommendation e2878.7. Venous Thromboembolism Prophylaxis in Hospitalized Patients: Recommendation e2888.8. Arginine Vasopressin Antagonists: Recommendation e2888.9. Inpatient and Transitions of Care: Recommendations e2889. Important Comorbidities in HF e2909.1. Atrial Fibrillation e2909.2. Anemia e2939.3. Depression e2939.4. Other Multiple Comorbidities e29310. Surgical/Percutaneous/Transcatheter Interventional Treatments of HF: Recommendations e29311. Coordinating Care for Patients With Chronic HF e29511.1. Coordinating Care for Patients With Chronic HF: Recommendations e29511.2. Systems of Care to Promote Care Coordination for Patients With Chronic HF e29611.3. Palliative Care for Patients With HF e29612. Quality Metrics/Performance Measures: Recommendations e29613. Evidence Gaps and Future Research Directions e299References e299Appendix 1. Author Relationships With Industry and Other Entities (Relevant) e320Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant) e323Appendix 3. Abbreviations e327PreambleThe medical profession should play a central role in evaluating the evidence related to drugs, devices, and procedures for the detection, management, and prevention of disease. When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve the quality of care, optimize patient outcomes, and favorably affect costs by focusing resources on the most effective strategies. An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist clinicians in selecting the best management strategy for an individual patient. Moreover, clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools.The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines (Task Force), charged with developing, updating, and revising practice guidelines for cardiovascular diseases and procedures, directs and oversees this effort. Writing committees are charged with regularly reviewing and evaluating all available evidence to develop balanced, patient-centric recommendations for clinical practice.Experts in the subject under consideration are selected by the ACCF and AHA to examine subject-specific data and write guidelines in partnership with representatives from other medical organizations and specialty groups. Writing committees are asked to perform a literature review; weigh the strength of evidence for or against particular tests, treatments, or procedures; and include estimates of expected outcomes where such data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein.In analyzing the data and developing recommendations and supporting text, the writing committee uses evidence-based methodologies developed by the Task Force.1 The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective or in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing committee reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing committee is the basis for LOE C recommendations and no references are cited. The schema for COR and LOE are summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Class III recommendations to delineate whether the recommendation is determined to be of “no benefit” or is associated with “harm” to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another have been added for COR I and IIa, LOE A or B only.Table 1. Applying Classification of Recommendation and Level of EvidenceTable 1. Applying Classification of Recommendation and Level of EvidenceIn view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline–recommended therapies (primarily Class I). This new term, GDMT, will be used herein and throughout all future guidelines.Because the ACCF/AHA practice guidelines address patient populations (and clinicians) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing committee reviews the potential influence of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation.The ACCF/AHA practice guidelines are intended to assist clinicians in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the clinician and patient in light of all the circumstances presented by that patient. As a result, situations may arise for which deviations from these guidelines may be appropriate. Clinical decision making should involve consideration of the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate.Prescribed courses of treatment in accordance with these recommendations are effective only if followed. Because lack of patient understanding and adherence may adversely affect outcomes, clinicians should make every effort to engage the patient’s active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing committee. All writing committee members and peer reviewers of the guideline are required to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. In December 2009, the ACCF and AHA implemented a new policy for relationship with industry and other entities (RWI) that requires the writing committee chair plus a minimum of 50% of the writing committee to have no relevant RWI (Appendix 1 includes the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing committee and are updated as changes occur. All guideline recommendations require a confidential vote by the writing committee and must be approved by a consensus of the voting members. Members are not permitted to draft or vote on any text or recommendations pertaining to their RWI. Members who recused themselves from voting are indicated in the list of writing committee members, and specific section recusals are noted in Appendix 1. Authors’ and peer reviewers’ RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing committee members’ comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at http://www.cardiosource.org/en/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of writing committees is supported exclusively by the ACCF and AHA without commercial support. Writing committee members volunteered their time for this activity.In an effort to maintain relevance at the point of care for practicing clinicians, the Task Force continues to oversee an ongoing process improvement initiative. As a result, in response to pilot projects, several changes to these guidelines will be apparent, including limited narrative text, a focus on summary and evidence tables (with references linked to abstracts in PubMed), and more liberal use of summary recommendation tables (with references that support LOE) to serve as a quick reference.In April 2011, the Institute of Medicine released 2 reports: Clinical Practice Guidelines We Can Trust and Finding What Works in Health Care: Standards for Systematic Reviews.2,3 It is noteworthy that the ACCF/AHA practice guidelines are cited as being compliant with many of the proposed standards. A thorough review of these reports and of our current methodology is under way, with further enhancements anticipated.The recommendations in this guideline are considered current until they are superseded by a focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA.Jeffrey L. Anderson, MD, FACC, FAHAChair, ACCF/AHA Task Force on Practice Guidelines1. Introduction1.1. Methodology and Evidence ReviewThe recommendations listed in this document are, whenever possible, evidence based. An extensive evidence review was conducted through October 2011 and includes selected other references through April 2013. Searches were extended to studies, reviews, and other evidence conducted in human subjects and that were published in English from PubMed, EMBASE, Cochrane, Agency for Healthcare Research and Quality Reports, and other selected databases relevant to this guideline. Key search words included but were not limited to the following: heart failure, cardiomyopathy, quality of life, mortality, hospitalizations, prevention, biomarkers, hypertension, dyslipidemia, imaging, cardiac catheterization, endomyocardial biopsy, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists/blockers, beta blockers, cardiac, cardiac resynchronization therapy, defibrillator, device-based therapy, implantable cardioverter-defibrillator, device implantation, medical therapy, acute decompensated heart failure, preserved ejection fraction, terminal care and transplantation, quality measures, and performance measures. Additionally, the committee reviewed documents related to the subject matter previously published by the ACCF and AHA. References selected and published in this document are representative and not all-inclusive.To provide clinicians with a representative evidence base, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm are provided in the guideline (within tables), along with confidence intervals and data related to the relative treatment effects such as odds ratio, relative risk, hazard ratio, and incidence rate ratio.1.2. Organization of the Writing CommitteeThe committee was composed of physicians and a nurse with broad expertise in the evaluation, care, and management of patients with heart failure (HF). The authors included general cardiologists, HF and transplant specialists, electrophysiologists, general internists, and physicians with methodological expertise. The committee included representatives from the ACCF, AHA, American Academy of Family Physicians, American College of Chest Physicians, American College of Physicians, Heart Rhythm Society, and International Society for Heart and Lung Transplantation.1.3. Document Review and ApprovalThis document was reviewed by 2 official reviewers each nominated by both the ACCF and the AHA, as well as 1 to 2 reviewers each from the American Academy of Family Physicians, American College of Chest Physicians, Heart Rhythm Society, and International Society for Heart and Lung Transplantation, as well as 32 individual content reviewers (including members of the ACCF Adult Congenital and Pediatric Cardiology Council, ACCF Cardiovascular Team Council, ACCF Council on Cardiovascular Care for Older Adults, ACCF Electrophysiology Committee, ACCF Heart Failure and Transplant Council, ACCF Imaging Council, ACCF Prevention Committee, ACCF Surgeons’ Scientific Council, and ACCF Task Force on Appropriate Use Criteria). All information on reviewers’ RWI was distributed to the writing committee and is published in this document (Appendix 2).This document was approved for publication by the governing bodies of the ACCF and AHA and endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American College of Chest Physicians, Heart Rhythm Society, and International Society for Heart and Lung Transplantation.1.4. Scope of This Guideline With Reference to Other Relevant Guidelines or StatementsThis guideline covers multiple management issues for the adult patient with HF. Although there is an abundance of evidence addressing HF, for many important clinical considerations, this writing committee was unable to identify sufficient data to properly inform a recommendation. The writing committee actively worked to reduce the number of LOE “C” recommendations, especially for Class I−recommended therapies. Despite these limitations, it is apparent that much can be done for HF. Adherence to the clinical practice guidelines herein reproduced should lead to improved patient outcomes.Although of increasing importance, HF in children and congenital heart lesions in adults are not specifically addressed in this guideline. The reader is referred to publically available resources to address questions in these areas. However, this guideline does address HF with preserved ejection fraction (EF) in more detail and similarly revisits hospitalized HF. Additional areas of renewed interest are in stage D HF, palliative care, transition of care, and quality of care for HF. Certain management strategies appropriate for the patient at risk for HF or already affected by HF are also reviewed in numerous relevant clinical practice guidelines and scientific statements published by the ACCF/AHA Task Force on Practice Guidelines, AHA, ACCF Task Force on Appropriate Use Criteria, European Society of Cardiology, Heart Failure Society of America, and the National Heart, Lung, and Blood Institute. The writing committee saw no need to reiterate the recommendations contained in those guidelines and chose to harmonize recommendations when appropriate and eliminate discrepancies. This is especially the case for device-based therapeutics, where complete alignment between the HF guideline and the device-based therapy guideline was deemed imperative.4 Some recommendations from earlier guidelines have been updated as warranted by new evidence or a better understanding of earlier evidence, whereas others that were no longer accurate or relevant or which were overlapping were modified; recommendations from previous guidelines that were similar or redundant were eliminated or consolidated when possible.The present document recommends a combination of lifestyle modifications and medications that constitute GDMT. GDMT is specifically referenced in the recommendations for the treatment of HF (Section 7.3.2). Both for GDMT and other recommended drug treatment regimens, the reader is advised to confirm dosages with product insert material and to evaluate carefully for contraindications and drug-drug interactions. Table 2 is a list of documents deemed pertinent to this effort and is intended for use as a resource; it obviates the need to repeat already extant guideline recommendations. Additional other HF guideline statements are highlighted as well for the purpose of comparison and completeness.Table 2. Associated Guidelines and StatementsTitleOrganizationPublication Year (Reference)Guidelines Guidelines for the Management of Adults With Congenital Heart DiseaseACCF/AHA20085 Guidelines for the Management of Patients With Atrial FibrillationACCF/AHA/HRS20116–8 Guideline for Assessment of Cardiovascular Risk in Asymptomatic AdultsACCF/AHA20109 Guideline for Coronary Artery Bypass Graft SurgeryACCF/AHA201110 Guidelines for Device-Based Therapy of Cardiac Rhythm AbnormalitiesACCF/AHA/HRS20134 Guideline for the Diagnosis and Treatment of Hypertrophic CardiomyopathyACCF/AHA201111 Guideline for Percutaneous Coronary InterventionACCF/AHA/SCAI201112 Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 UpdateAHA/ACCF201113 Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart DiseaseACCF/AHA/ACP/AATS/PCNA/SCAI/STS201214 Guideline for the Management of ST-Elevation Myocardial InfarctionACCF/AHA201315 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial InfarctionACCF/AHA201316 Guidelines for the Management of Patients With Valvular Heart DiseaseACCF/AHA200817 Comprehensive Heart Failure Practice GuidelineHFSA201018 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart FailureESC201219 Chronic Heart Failure: Management of Chronic Heart Failure in Adults in Primary and Secondary CareNICE201020 Antithrombotic Therapy and Prevention of ThrombosisACCP201221 Guidelines for the Care of Heart Transplant RecipientsISHLT201022Statements Contemporary Definitions and Classification of the CardiomyopathiesAHA200623 Genetics and Cardiovascular DiseaseAHA201224 Appropriate Utilization of Cardiovascular Imaging in Heart FailureACCF201325 Appropriate Use Criteria for Coronary Revascularization Focused UpdateACCF201226 Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureNHLBI200327 Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III GuidelinesNHLBI200228 Referral, Enrollment, and Delivery of Cardiac Rehabilitation/Secondary Prevention Programs at Clinical Centers and BeyondAHA/AACVPR201129 Decision Making in Advanced Heart FailureAHA201230 Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient SelectionAHA201231 Advanced Chronic Heart FailureESC200732 Oral Antithrombotic Agents for the Prevention of Stroke in Nonvalvular Atrial FibrillationAHA/ASA201233 Third Universal Definition of Myocardial InfarctionESC/ACCF/AHA/WHF201234AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; AATS, American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; ACCP, American College of Chest Physicians; ACP, American College of Physicians; AHA, American Heart Association; ASA, American Stroke Association; ESC, European Society of Cardiology; HFSA, Heart Failure Society of America; HRS, Heart Rhythm Society; ISHLT, International Society for Heart and Lung Transplantation; NHLBI, National Heart, Lung, and Blood Institute; NICE, National Institute for Health and Clinical Excellence; PCNA, Preventive Cardiovascular Nurses Association; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; and WHF, World Heart Federation.2. Definition of HFHF is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, a

Jennifer L. Peura, MD, Chair; Monica Colvin-Adams, MD, MS, FAHA, Co-Chair; Gary S. Francis, MD, FAHA; Kathleen L. Grady, PhD, APN, FAHA; Timothy M. Hoffman, MD, FAHA; Mariell Jessup, MD, FAHA; Ranjit John, MD; Michael S. Kiernan, MD; Judith E. Mitchell, MD, FAHA; John B. O’Connell, MD; Francis D. Pagani, MD, PhD, FAHA; Michael Petty, PhD, RN; Pasala Ravichandran, MD; Joseph G. Rogers, MD; Marc J. Semigran, MD, FAHA; J. Matthew Toole, MD, FAHA; on behalf of the American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia

HomeCirculationVol. 126, No. 22Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBRecommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient SelectionA Scientific Statement From the American Heart Association Jennifer L. Peura, MD, Chair, Monica Colvin-Adams, MD, MS, FAHA, Co-Chair, Gary S. Francis, MD, FAHA, Kathleen L. Grady, PhD, APN, FAHA, Timothy M. Hoffman, MD, FAHA, Mariell Jessup, MD, FAHA, Ranjit John, MD, Michael S. Kiernan, MD, Judith E. Mitchell, MD, FAHA, John B. O'Connell, MD, Francis D. Pagani, MD, PhD, FAHA, Michael Petty, PhD, RN, Pasala Ravichandran, MD, Joseph G. Rogers, MD, Marc J. Semigran, MD, FAHA and J. Matthew Toole, MD, FAHAon behalf of the American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical CardiologyCouncil on Cardiopulmonary, Critical Care, Perioperative and ResuscitationCouncil on Cardiovascular Disease in the YoungCouncil on Cardiovascular NursingCouncil on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia Jennifer L. PeuraJennifer L. Peura , Monica Colvin-AdamsMonica Colvin-Adams , Gary S. FrancisGary S. Francis , Kathleen L. GradyKathleen L. Grady , Timothy M. HoffmanTimothy M. Hoffman , Mariell JessupMariell Jessup , Ranjit JohnRanjit John , Michael S. KiernanMichael S. Kiernan , Judith E. MitchellJudith E. Mitchell , John B. O'ConnellJohn B. O'Connell , Francis D. PaganiFrancis D. Pagani , Michael PettyMichael Petty , Pasala RavichandranPasala Ravichandran , Joseph G. RogersJoseph G. Rogers , Marc J. SemigranMarc J. Semigran and J. Matthew TooleJ. Matthew Toole and on behalf of the American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiologyand Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitationand Council on Cardiovascular Disease in the Youngand Council on Cardiovascular Nursingand Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia Originally published29 Oct 2012https://doi.org/10.1161/CIR.0b013e3182769a54Circulation. 2012;126:2648–2667Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2012: Previous Version 1 IntroductionThe era of mechanical circulatory support (MCS) began in 1953 with the development of cardiopulmonary bypass to facilitate open heart surgery.1 In 1964, the National Heart Institute (now the National Heart, Lung, and Blood Institute) funded the Artificial Heart Program and became actively involved in MCS development. This led to requests for Proposals issued in 1977 and 1980, which laid the foundation for the development of implantable MCS for long-term use, including devices capable of hospital discharge, in the 1990s. Although heart transplantation is now commonplace at many hospitals, the inadequate supply of donor hearts and patient contraindications to transplantation continue to severely restrict its application. As the demand for long-term replacement of diseased hearts increases, there is a clear need for innovative, safe, and durable MCS to treat the growing population of patients with advanced heart failure (HF). Many exciting changes in the field of MCS have occurred in the past few years, including the development of smaller portable pumps and the concept of destination therapy (DT), or permanent pump placement as an alternative to heart transplantation. Currently, there are no published guidelines for the use of MCS. Thus, it is our intent that this statement will provide the contemporary cardiologist and other HF providers with an understanding of general considerations when determining the appropriateness of MCS.Definition of Advanced HFThere is little hope that complete consensus will ever be reached on the definition of advanced HF, but most physicians caring for such patients on a regular basis readily identify the characteristics of these patients. Advanced HF patients are those with clinically significant circulatory compromise who require special care, including consideration for heart transplantation, continuous intravenous inotropic therapy, MCS, or hospice.2,3 Typically, such patients have symptoms at rest or with minimal exertion and cannot perform many activities of daily living.3 Commonly used objective measures of functional limitations include a peak Vȯ2 ≤14 mL · kg−1 · min−1 (or <50% of expected) and a 6-minute walk distance <300 m.3 Many have cardiac cachexia, are failing or intolerant of conventional HF therapy, and require repeated hospitalization for more intensive management.4 Advanced HF patients usually have a life expectancy of <2 years without heart transplantation or MCS, and ≈50 000 patients each year in the United States die of advanced HF.4Options for Advanced HFWhen a patient presents with advanced HF, a candid discussion of prognosis is appropriate. In addition to a review of advanced therapies such as transplantation and MCS, the benefits of and drawbacks to resuscitation and deactivation of defibrillators and the choice of a family spokesperson or surrogate should be addressed with the patient and the patient's family. On occasion, outpatient intravenous inotropic agents are prescribed, but these drugs are strictly palliative and can foreshorten life.5,6 Palliative inotropic therapy should be reserved for only those patients who have a reproducible and marked improvement in symptoms with inotropic therapy. Hospice has traditionally been reserved for patients with a life expectancy of ≤6 months, but this operational policy may be difficult in the setting of advanced HF because healthcare providers cannot accurately predict the end of life in such patients. Policies are being revised to allow patients with HF to benefit from hospice services.Heart transplantation remains the definitive therapy for advanced and refractory HF. However, heart transplantation remains challenged by inadequate donor supply, finite graft survival, and long-term complications of immunosuppressive therapy. Thus, there is a need for more refined and durable MCS options. The recent development of smaller, more durable, and safer ventricular assist devices (VADs) has enabled MCS to emerge as a practical and effective form of therapy, either until heart transplantation can be performed (as bridge to transplantation [BTT]) or increasingly as an alternative to transplantation as DT.As the MCS field evolves, practitioners caring for advanced HF patients will require an understanding of the appropriate application of MCS. In addition, an increasing number of community programs seek to provide alternative therapy for HF. As MCS use and management move beyond the purview of academic transplant centers, it is essential that the indications for MCS and the essentials of device management are broadly understood. Although we have provided a summary of current professional society guidelines in Table 1, it could be argued that the expanding use of MCS is not reflected in current guideline statements.7–11 Accordingly, in this statement, we provide recommendations based on currently available data and the consensus of leaders in the field of MCS.Table 1. Current Recommendations for MCSACCF/AHA 2009 HF guidelines7 Consideration of an LVAD as permanent or destination therapy is reasonable in highly selected patients with refractory end-stage HF and an estimated 1-year mortality >50% with medical therapy (Class II; Level of Evidence B)HFSA comprehensive HF practice guidelines8 Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for an MCS device as a BTT (Level of Evidence B) Permanent mechanical assistance with an implantable LVAD may be considered in highly selected patients with severe HF refractory to conventional therapy who are not candidates for heart transplantation, particularly those who cannot be weaned from intravenous inotropic support at an experienced HF center (Level of Evidence B) Patients with refractory HF and hemodynamic instability and/or compromised end-organ function with relative contraindications to cardiac transplantation or permanent MCS expected to improve with time or restoration of an improved hemodynamic profile should be considered for urgent MCS as a bridge to decision; these patients should be referred to a center with expertise in the management of patients with advanced HF (Level of Evidence C)Canadian HF guidelines9 MCS may be offered to selected individuals with end-stage heart failure who are inotrope dependent and do not meet the traditional criteria for cardiac transplantation (Class IIb; Level of Evidence B)ESC guidelines 2008/201010,11 Current indications for LVADs and artificial hearts include bridging to transplantation and managing patients with acute, severe myocarditis (Class IIa; Level of Evidence C) Although experience is limited, these devices may be considered for long-term use when no definitive procedure is planned (Class IIb; Level of Evidence C) LVAD may be considered as destination treatment to reduce mortality (Class IIa; Level of Evidence B)MCS indicates mechanical circulatory support; AHA, American Heart Association; ACCF, American College of Cardiology Foundation; HF, heart failure; LVAD, left ventricular assist device; HFSA, Heart Failure Society of America; BTT, bridge to transplantation; and ESC, European Society of Cardiology.Management Strategies for the MCS PatientSelection Criteria and Decision ProcessThe approach to MCS is determined by the trajectory of HF progression and overall clinical status. Because there are temporary and durable device options, extracorporeal, implantable, or percutaneous strategies for MCS are as broad and variable as the patients requiring this therapy. MCS may be used as a BTT for transplantation-eligible patients and as DT for those who are transplantation ineligible. These designations are fluid, however, because the patient's candidacy for either therapy may change over time (Figure 1). For example, a DT patient may become transplant eligible after significant improvement in comorbidities that previously precluded consideration for transplantation. Alternatively, a transplantation-eligible patient may become ineligible after MCS because of perioperative complications, progression of comorbidities, or personal preference. In circumstances when a patient presents in cardiogenic shock, it may not be possible to fully determine candidacy for transplantation. MCS may be used to determine neurological recovery and to stabilize potentially reversible comorbidities. In these situations, MCS is used as a bridge to decision or bridge to recovery.Download figureDownload PowerPointFigure 1. Device selection flow chart. OHTx indicates orthotopic heart transplantation; IABP, intra-aortic balloon pump; ECMO, extracorporeal membrane oxygenation; pVAD, Paracorporeal Ventricular Assist Device; BTT, bridge to transplantation; DT, destination therapy; and BTD, bridge to decision.It is important to underscore 2 important principles that have evolved over the past decade. First, some patients are too profoundly ill with multisystem organ failure to benefit from the very best of MCS and aggressive inotropic therapy. Second, complex decisions about candidacy for transplantation or MCS are best made by an experienced, multidisciplinary team. Although it may become appropriate for smaller programs to implant elective DT MCS in highly selected patients, more acutely ill patients should be referred to quaternary care hospitals that are accustomed to the management of such patients. In the following sections, strategies for MCS are discussed.Indications for MCSBridge to RecoveryThe first application of extracorporeal MCS focused on temporary maintenance of the circulation after an acute event until the occurrence of cardiac recovery. The earliest clinical example was the use of MCS in patients with postcardiotomy shock in whom failure to wean from cardiopulmonary bypass was considered certain death unless the patient could be rescued with temporary MCS. This pattern established the concept and indication of bridge to recovery in which temporary MCS sustained the circulation until cardiac recovery. A robust experience with temporary MCS for failure to wean from bypass led to the application of MCS in nonpostcardiotomy settings such as cardiogenic shock caused by myocardial infarction, fulminant or acute myocarditis, or acute cardiac allograft dysfunction after heart transplantation.Compared with early options for MCS, modern devices (Table 2) provide longer duration and more versatile support. These devices, called nondurable MCS, may be used as a first step when rapid support is necessary in patients with cardiogenic shock who are at too high a risk for implantation of a durable device or as an alternative to durable implantable devices if recovery is possible. For these patients, a bridge with a nondurable device provides essential stabilization and permits clarification and potential reversal of the other medical issues that may interfere with a satisfactory outcome after transplantation or long-term device placement. The following nondurable devices are used for bridge to recovery and for temporary support until more definitive therapies can be used in patients in whom myocardial recovery does not occur.Table 2. Devices Available for Short-Term MCSDeviceManufacturerMechanismPositionDurationIABPMultipleCounterpulsationNADaysECMOMultipleCPBNADays–weeksBVS5000, AB5000ABIOMEDPulsatileR, L, or BilateralWeeksThoratec pVADThoratecPulsatileR, L, or BilateralWeeksCentriMagLevitronixCentrifugalR, L, or BilateralWeeksTandemHeartCardiacAssistCentrifugalpMCSDaysImpellaABIOMEDAxial flowpMCSDaysMCS indicates mechanical circulatory support; IABP, intra-aortic balloon pump; NA, not applicable; ECMO, extracorporeal membrane oxygenation; CPB, cardiopulmonary bypass; R, right; L, left; pVAD, percutaneous ventricular assist device; and pMCS, percutaneous mechanical circulatory support.Intra-Aortic Balloon PumpThe intra-aortic balloon pump (IABP) is broadly used and is commonly the first step in the treatment of cardiogenic shock. The IABP provides hemodynamic support for cardiogenic shock by diastolic augmentation of aortic pressure and left ventricular afterload reduction. Coronary perfusion is also increased, which may be important in the setting of increased ventricular diastolic pressure, even in the absence of critical coronary artery stenosis. Although relatively easy to insert in the community setting, the use of the IABP is limited to short durations of support because of potential arterial complications and the inability to mobilize patients. It may be insufficient in the setting of marked cardiac failure.Extracorporeal Membrane OxygenationExtracorporeal membrane oxygenation (ECMO) is used to treat medically refractory cardiogenic shock when there is poor oxygenation, and ECMO can be a rapid option for emergency biventricular support. ECMO uses a nonpulsatile pump, membrane oxygenator, and inflow and outflow cannulas. Arterial and venous access can be obtained via peripheral cannulation of the femoral vessels, which can be applied rapidly at the bedside.12 Survival of patients treated with ECMO reflects the critical nature of the patients in whom it is used. In adults, 1 study reported 58% survival to hospital discharge,13 and another reported survival rates of 76% (3 days), 38% (30 days), and 24% (5 years).14 In the pediatric population, ECMO use is more prevalent,12 yet survival is still modest (43%–54%).15,16 Outcomes may be improved when ECMO is used for specific indications such as acute myocarditis, in which survival was reported to be as high as 83% in pediatric17 and 75% in adult18 patients. Major limitations for the use of ECMO remain its lack of durability (weeks of support), limited availability, necessary perfusion support, and complications related to vascular access.Extracorporeal MCSEarly pulsatile, extracorporeal devices provided salvage support for patients in cardiogenic shock who otherwise faced an extremely high risk of mortality.19 These extracorporeal devices were implanted via a traditional sternotomy with an external pumping chamber and drive console (Figure 2). The first of these devices was the Abiomed BVS5000 (ABIOMED, Inc, Danvers, MA), a nondurable, extracorporeal, pulsatile, pneumatic device with a large external controller. It was approved by the US Food and Drug Administration (FDA) after a prospective, nonrandomized, multicenter trial of 55 patients with postcardiotomy shock. Fifty-five percent of patients were weaned from support, and 29% of patients survived to discharge.20 The following pulsatile pumps have been approved for rescue therapy: Abiomed AB5000 (ABIOMED, Inc) and the Thoratec Paracorporeal Ventricular Assist Device II (Thoratec Corp, Pleasanton, CA). Survival with the Paracorporeal Ventricular Assist Device was 48% in a nonrandomized trial of 29 patients with postcardiotomy shock.21–23 Finally, the CentriMag (Levitronix LLC, Waltham, MA) is a nondurable, extracorporeal, continuous, centrifugal-flow pump with a magnetically levitated rotor and external controller that is designed to support the left, right, or both ventricles.24,25 This system is capable generating flows up to 10 L/min under normal physiological conditions. The CentriMag may also be used to provide temporary right ventricular (RV) support after left VAD (LVAD) insertion and has FDA approval for use for up to 30 days for this indication. In a multicenter study, 38 patients with cardiogenic shock were supported with CentriMag, and overall 30-day survival was 47%.26 Several studies have reported support with the CentriMag system for >100 days without any instances of pump failure or thromboembolic events.27 Some centers are using the CentriMag device for ECMO support, allowing rapid initiation of biventricular support.Download figureDownload PowerPointFigure 2. Device diagrams. Reprinted with permission from Thoratec and from CardiacAssist.Percutaneous MCSThe TandemHeart (CardiacAssist, Inc, Pittsburgh, PA) is a nondurable, percutaneous, continuous-flow centrifugal pump with an external controller. It can be placed in the cardiac catheterization laboratory and generates up to 5 L/min of flow. This device uses transseptal left atrial inflow via a percutaneous femoral venous cannula and outflow via a contralateral femoral arterial cannula.28,29 Removal of the device is done at the bedside or at the time of durable MCS surgery or transplantation. The device was designed to temporarily support patients during high-risk percutaneous interventions in the cardiac catheterization laboratory and has been used successfully for postcardiotomy HF and cardiogenic shock. This device is appealing as an alternative in patients with refractory cardiogenic shock because it has the potential to avoid the morbidity and mortality associated with surgical device placement. Complications of this device include bleeding, thrombosis, leg ischemia, and dislocation of transseptal or atrial cannulas. Support with the TandemHeart is reported to improve cardiac indexes, blood pressure, and mixed venous oxygen saturation30 and to reverse the terminal hemodynamic compromise seen in patients with cardiogenic shock refractory to IABP and vasopressor support.31The Impella 2.5 (ABIOMED, Inc) is a nondurable, percutaneous, continuous-flow, axial pump with an external controller. The simple design is a significant advantage for this device, allowing straightforward percutaneous insertion and rapid initiation of circulatory support in the catheterization laboratory. This device rests across the aortic valve and pumps up to 2.5 L/min of blood from the left ventricle to the ascending aorta. The Impella 2.5 may be used to support high-risk coronary angioplasty and for patients with myocardial infarction complicated by cardiogenic shock.32 Compared with treatment with IABP, the Impella 2.5 device provided superior hemodynamic support and was both feasible and safe; however, there was no difference in 30-day mortality between the 2 groups. With a maximum flow of 2.5 L/min, the use of the Impella 2.5 may be limited in patients with a large body mass index (BMI) or in those who are in cardiogenic shock and require more flow. The Impella 5.0 is of the same design, is slightly larger, and is capable of delivering 5-L/min flow. The Impella 5.0 was approved by the FDA (April 2009) for providing temporary circulatory support; however, it requires a surgical cut-down on a peripheral artery for insertion. Complications of the Impella device include bleeding, thrombosis, and limb ischemia.33,34Withdrawal of Nondurable MCSPatients who receive nondurable MCS (either percutaneous or surgically placed) should always be evaluated for possible ventricular recovery, particularly in the setting of postcardiotomy shock, myocardial infarction, or myocarditis. Weaning can be performed by assessing clinical parameters (hemodynamics and echocardiographic left ventricular function) while MCS is temporarily reduced. Although uniform guidelines for weaning MCS do not exist, it is common practice to reduce flows by 0.5 L/min while simultaneously assessing the clinical status and hemodynamics. Ventricular recovery can be detected first by the presence of native ventricular ejection on the arterial or pulmonary artery wave forms. Subsequent confirmation of recovery of ventricular function is best performed by either transthoracic or transesophageal echocardiography. It is important to confirm the presence of adequate anticoagulation and to optimize hemodynamics with invasive monitoring before weaning MCS and explantation. Percutaneous MCS can be removed at the bedside unless a femoral cut-down is performed for placement. Surgically placed MCS devices are preferably removed in the operating room, although a variety of minimally invasive techniques are being developed to facilitate easier removal.Clinical Perspective: Bridge to RecoveryTo achieve the best short-term and long-term survival, MCS must be initiated in an appropriate and timely fashion.35 Often, the patient with cardiogenic shock may also have multisystem organ failure and demonstrate an uncertain neurological status at the time of evaluation for MCS. In this situation, implantation of durable MCS is associated with poor outcomes and is not cost-effective. Implantation of nondurable MCS as a bridge to decision allows support until the clinical situation justifies the implantation of a more permanent device.36An increasing number of centers are using nondurable MCS as a means to achieve clinical stability before transfer to a specialized advanced HF center for more definitive therapy. Quick and appropriate intervention with MCS can allow stabilization and facilitate safe patient transfer, ultimately improving patient survival in the setting of cardiogenic shock. A multidisciplinary approach and excellent communication between local hospitals and specialized MCS centers can make this an effective strategy.37 It is particularly important that the advanced HF center is involved in planning for definitive therapy as early as possible, particularly before the performance of high-risk invasive procedures involving coronary angioplasty, cardiac surgery, or ventricular tachycardia ablation.Two important questions must be considered in patients with acute cardiogenic shock who are potential candidates for permanent support: (1) Which patients will benefit from temporary MCS? (2) What modality of nondurable MCS should be used? Considering the ongoing rapid evolution of these devices with concomitant improvements in efficacy and safety, the recommendation is to use the device that is familiar to the team and can best serve the needs of the patient.Bridge to TransplantationThe development of durable, implantable MCS devices was initially conceived as permanent support of the heart as an alternative to heart transplantation. However, FDA concerns about the long-term performance and safety largely restricted the initial use of implantable MCS devices to patients eligible for heart transplantation, not for patients as DT. This bias by clinicians and the FDA to limit MCS to transplant-eligible patients set the early stage for what has become the BTT indication. It also led to the regulatory pathway by which most long-term, implantable MCS devices are evaluated today. Devices with FDA approval for BTT are listed in Table 3 and described below.Table 3. Devices Approved by the FDA for Long-Term MCSDeviceManufacturerMechanismPositionIndicationsPortableThoratec pVADThoratecPulsatileR, L, or bilateralBTT, BTRYesNovacorWorld HeartPulsatileLBTT, DTYesHeartmate XVEThoratecPulsatileLBTT, DTYesHeartmate IIThoratecAxial flowLBTT, DTYesAbiomed TAHABIOMEDPulsatileBilateralBTTYes/NoCardioWest TAHSyncardiaPulsatileBilateralBTTNoBerlin EXOR PediatricBerlinPulsatile/pneumaticR, L, or bilateralBTTNoDeBakey ChildMicroMedContinuousLBTT, BTRNoFDA indicates Food and Drug Administration; MCS, mechanical circulatory support; pVAD, percutaneous ventricular assist device, R, right; L, left; BTT, bridge to transplantation; BTR, bridge to recovery; DT, destination therapy; and TAH, total artificial heart.Extracorporeal MCSThe Thoratec Paracorporeal Ventricular Assist Device II received FDA approval for BTT in 1995. With its smaller portable external driver, patients may be discharged from the hospital to await heart transplantation.38 In a review of 84 patients in a single center, survival was reported to be 56%, with 79% of patients alive 1 year after heart transplantation.39A single option for BTT in the pediatric population is the Berlin EXCOR VAD (Berlin Heart, GmbH, The Woodlands, TX), which was recently approved by the FDA. This device is an extracorporeal, pulsatile, pneumatic pump for left or biventricular support. In a report on its use in 73 children,40 overall mortality was 23%, with younger age and need for biventricular support predicting mortality by multivariable analysis.Implantable MCSThe Thoratec HeartMate vented electric XVE (Thoratec Corp) and the Novacor LVAD system (Novacor LVAS, Baxter, Oakland, CA)41 were early implantable, pulsatile, pneumatic devices with small external controllers. These devices are largely historical and are not used today. Broad implementation of the pulsatile devices for BTT was limited by the large size of the implantable pumps and the risk of device failure (reported to be 35% at 24 months).42The next generation of implantable MCS technology brought smaller and more durable devices. The current era includes continuous-, axial-, and centrifugal-flow devices.43 The HeartMate II (Thoratec Corp) is an implantable, continuous, axial-flow device with a small external controller. This device has a single moving part and a much smaller profile than earlier HeartMate devices. The HeartMate II was approved by the FDA for BTT in April 2008. In a prospective, noncontrolled, multicenter trial including 281 patients, survival was 82% at 6 months and 73% at 12 months.44 At 6 months, there was significant improvement in the 6-minute walk test, with the majority (83%) of patients in New York Heart Association (NYHA) functional class I or II. Improvement in quality of life was also recorded in patients treated as BTT. This device showed improved durability, with pump replacement required in only 4% of patients.45The MicroMed DeBakey, a continuous, axial-flow pump, is not approved by the FDA for use in adults but is available for use in children 5 to 16 years of age. Because of its small size, the MicroMed DeBakey provides an important option for children for whom there are few alternatives for MCS.46Total Artificial HeartThe earliest successes in MCS technology occurred with the total artificial heart. The original Jarvik 7–100 was used to support patients with severe HF, but its clinical application was limited by large device size and a high rate of stroke and infection. The CardioWest total artificial heart (Syncardia Systems Inc, Tucson, AZ) is an implantable, pulsatile, pneumatic pump with an external controller. It received FDA approval as a BTT in 200447 and is a modern version of the original Jarvik 7. In a multicenter trial, survival to transplantation was 79% among 81 patients supported with this device compared with 46% in the 35-patient historical medical therapy alone control group. Posttransplantation survival was superior for patients supported with the CardioWest total artificial heart (86% at 1 year, 64% at 5 years) compared with control subjects (69% at 1 year, 34% at 5 years). A portable driver for this device that would allow discharge from the hospital on support is under investigation. Development of the total artificial heart was eclipsed by the rapid growth of VAD technology; currently, the total artificial heart is reserved for patients who have severe biventricular failure and require MCS.Clinical Perspective: BTTThe number of heart transplantations performed annually (2200 per year)48 is much less than the number of patients with advanced HF. The emergence of MCS as BTT has clearly affected patient care, with 43% of all listed heart transplant recipients receiving MCS while awaiting a donor organ (http://www.srtr.org).48Mortality among patients listed for heart transplantation is considerable, especially among the inotrope-dependent population, in