Judith E. Mitchell

Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection A Scientific Statement From the American Heart Association

The 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. There 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 …

2013 ACCF/AHA Guideline for the Management of Heart Failure

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,

Outcome in African Americans and other minorities in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

BACKGROUND The SCD-HeFT demonstrated that implantable cardioverter/defibrillator (ICD) therapy significantly improved survival compared to medical therapy alone in stable moderately symptomatic heart failure patients with an ejection fraction < or = 35%. The purpose of this report is to describe the outcomes in African Americans (AAs) and other minorities. METHODS Of 2521 patients enrolled, 23% were minorities and 17% were AAs. Baseline demographic, clinical variables, socioeconomic status, and long-term outcomes were compared according to race. Two major prespecified subgroups were examined: heart failure cause (ischemic vs nonischemic) and New York Heart Association class (II vs III). RESULTS At baseline, compared to whites, AAs were younger and had more nonischemic heart failure, lower ejection fractions, worse New York Heart Association functional class, and higher prevalence of a history of nonsustained ventricular tachycardia. Comparable percentages of whites and AAs held paid jobs, but whites had a significantly higher educational level and household income (P = .001). Compliance with ICD implantation and medical therapy was comparable in both subgroups. No significant difference was observed in the rate of ICD discharge among whites and AAs. Adjusted mortality risk was significantly higher in AAs compared to whites (hazard ratio 1.27, P = .038). Mortality was equally reduced in both race groups receiving ICD therapy compared to placebo (hazard ratio 0.65 in AAs and 0.73 in whites). CONCLUSIONS Survival benefits from ICD therapy in SCD-HeFT were not dependent on race. In addition, in this clinical trial setting, there was no evidence that AAs were less willing to accept ICD therapy than whites.

Self‐Care for the Prevention and Management of Cardiovascular Disease and Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association

Abstract 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.

Obstructive sleep apnea and cardiovascular disease in blacks: A call to action from the Association of Black Cardiologists

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.

Treatment of Heart Failure in African Americans— A Call to Action

Advances in heart failure treatment have not necessarily translated into equity in improved outcomes for African Americans. Heart failure in African Americans is characterized by a higher prevalence, especially at younger ages; more-adverse course with more frequent hospitalizations; and higher mortality rates compared to the general population. Despite this distinct disease profile, African Americans are remarkably underrepresented in large heart failure trials. This paper reviews the unique course of heart failure in African Americans and discusses treatment in the context of clinical trial evidence. African Americans with heart failure may respond differently to some standard therapies compared to whites, but low levels of enrollment of AAs in large clinical trials preclude valid conclusions in certain cases. An important exception is the African American Heart Failure Trial (AHeFT), a well-designed, prospective, randomized, placebo-controlled, double-blind study, that added a combination of fixed-dose isosorbide dinitrate/hydralazine (ISDN/ HYD) to standard therapy and showed a 43% improvement in survival and a 33% reduction in first hospitalizations. Despite compelling evidence from AHeFT, post hoc secondary analyses, and recommendations from current practice guidelines, ISDN/HYD remains underutilized in African Americans with heart failure. In this paper, we put forth a call to action for racial equity in clinical research and treatment in African Americans with heart failure.

Recommendations for the Use of Mechanical Circulatory Support: Ambulatory and Community Patient Care: A Scientific Statement from the American Heart Association

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. View this table: Table 1. Indications and Contraindications to Durable Mechanical Support 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. Currently in the United States, the most frequently used durable devices are continuous-flow devices with …

Atrial fibrillation and mortality in African American patients with heart failure: Results from the African American Heart Failure Trial (A-HeFT)

BACKGROUND Atrial fibrillation (AF) is common in patients with heart failure (HF) and portends a worsened prognosis. Because of the low enrollment of African American subjects (AAs) in randomized HF trials, there are little data on AF in AAs with HF. This post hoc analysis reviews characteristics and outcomes of AA patients with AF in A-HeFT. METHODS AND RESULTS A total of 1,050 AA patients with New York Heart Association class III/IV systolic HF, well treated with neurohormonal blockade (87% β-blockers, 93% angiotensin-converting enzyme inhibitor and/or angiotensin receptor blocker), were randomized to an added fixed-dose combination of isosorbide dinitrate/hydralazine (FDC I/H) or placebo. Atrial fibrillation was confirmed in 174 (16.6%) patients at baseline and in an additional 9 patients who developed AF during the study, for a final cohort of 183 (17.4%). Comparison of patients with AF versus no AF revealed the following: mean age 61 ± 12 versus 56 ± 13 years (P < .001), systolic blood pressure (BP) 124 ± 18 versus 127 ± 18 mm Hg (P = .044), diastolic BP 74 ± 11 versus 77 ± 10 mm Hg (P = .002), creatinine level 1.4 ± 0.5 versus 1.2 ± 0.5 mg/dL (P < .001), and brain natriuretic peptide 431 ± 443 versus 283 ± 396 pg/mL (P < .001). No significant difference was observed in ejection fraction, left ventricular end-diastolic diameter, or quality-of-life scores. However, AF increased the risk of mortality significantly among AA patients (P = .018), and the use of FDC I/H reduced the risk of mortality in patients with AF (HR 0.21, P = .002). CONCLUSION African Americans with HF and AF (vs no AF) were older, had lower BP, and had higher creatinine and brain natriuretic peptide levels. Mortality and morbidity were worse when AF was present, and these data suggest that there may be an enhanced survival benefit with the use of FDC I/H in AA patients with HF and AF.

New guidelines for heart failure focus on prevention.

Heart failure is the only major cardiovascular disease thats increasing in incidence and prevalence in the United States. Because heart failure is a preventable disease, the 2002 heart failure guidelines devise a new staging system that expands the continuum of care to encompass prevention.

Is Our Health Care System Equipped for the Changing Heart Failure Demographics

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