Monica Colvin

2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America

Glenn N. Levine, MD, FACC, FAHA, Chair Patrick T. O’Gara, MD, FACC, FAHA, Chair-Elect Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair [‡‡][1] Sana M. Al-Khatib, MD, MHS, FACC, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA Ralph G. Brindis, MD,

OPTN/SRTR 2015 Annual Data Report: Heart

The number of heart transplant candidates and transplants performed continued to rise each year. In 2015, 2819 heart transplants were performed. In addition, the number of new adult candidates on the waiting list increased 51% since 2004. The number of adult heart transplant survivors continued to increase, and in 2015, 29,172 recipients were living with heart transplants. Patient mortality following transplant has declined. The number of pediatric candidates and transplants performed also increased. New listings for pediatric heart transplants increased from 451 in 2004 to 644 in 2015. The number of pediatric heart transplants performed each year increased from 297 in 2004 to 460 in 2015. Among pediatric patients who underwent transplant in 2014, death occurred in 7.2% at 6 months and 9.6% at 1 year.

Antibody-Mediated Rejection in Cardiac Transplantation: Emerging Knowledge in Diagnosis and Management A Scientific Statement From the American Heart Association

Antibody-mediated rejection (AMR) of the cardiac allograft is a poorly defined and challenging diagnosis for transplant recipients and their clinicians. Although even its very existence in heart transplantation was debated until relatively recently, improved immunopathologic and serological techniques to detect myocardial capillary complement deposition and circulating anti-HLA (human leukocyte antigen) antibodies have led to the detection of a spectrum of newly uncovered immunologic changes that characterize AMR. The earliest standardized clinical and pathological criteria for the diagnosis of AMR in heart transplantation became available in 2004, the result of a task force assembled by the International Society for Heart and Lung Transplantation (ISHLT). In 2006, the criteria were refined by the ISHLT Immunopathology Task Force (Table 1). These revisions provide 4 categories of diagnostic criteria: clinical, histopathologic, immunopathologic, and serological assessment.1 Despite these published criteria, currently >50% of heart transplant centers make the diagnosis of AMR based on cardiac dysfunction and the lack of cellular infiltrates on the heart biopsy (preconference survey included in the ISHLT consensus article).2 More recently, the ISHLT Consensus Conference on AMR has redefined the pathological diagnosis of AMR.3 The 2013 ISHLT “Working Formulation for the Standardization of Nomenclature in the Pathologic Diagnosis of Antibody-Mediated Rejection in Heart Transplantation” was published in December 2013. This document provided an update to the 2010 consensus conference.4 It is anticipated that this update to the definition of AMR will reduce variations in the diagnosis of AMR, providing a platform for the development of standardized therapies. The goal of the present scientific statement is to provide the heart transplant professional with an overview of the current status of the diagnosis and treatment of AMR in the cardiac allograft based on recent consensus conferences and the published literature. We include recommendations to facilitate evolving standardization and strategies …

Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement from the American Heart Association

The intent of this American Heart Association (AHA) scientific statement is to summarize our current understanding of dilated cardiomyopathies. There is special emphasis on recent developments in diagnostic approaches and therapies for specific cardiomyopathies. Recommendations in this document are based on published studies, published practice guidelines from the American College of Cardiology (ACC)/AHA1 and other organizations,2,3 and the multidisciplinary expertise of the writing group. Existing evidence in epidemiology, classification, diagnosis, and management of specific cardiomyopathies is usually derived from nonrandomized observational studies, registries, case reports, or expert opinion based on clinical experience, not large-scale randomized clinical trials or systematic reviews. Therefore, in this document, rather than using the standard ACC/AHA classification schema of recommendations and level of evidence,4 we have included key management strategies at the end of each section and categorized our recommendations according to the level of consensus. Although the format of our recommendations might resemble the ACC/AHA classification of recommendations used in the ACC/AHA practice guidelines, because of the preponderance of expert opinion or level of evidence C evidence in our document, we elected to use different terminology to provide a distinction from the practice guidelines, in which stronger levels and quality of evidence with randomized clinical trials or meta-analyses are usually present.4 The levels of evidence follow the AHA and ACC methods of classifying the level of certainty of the treatment effect.4 The term dilated cardiomyopathy (DCM) refers to a spectrum of heterogeneous myocardial disorders that are characterized by ventricular dilation and depressed myocardial performance in the absence of hypertension, valvular, congenital, or ischemic heart disease.5 In clinical practice, the pathogenesis of heart failure (HF) has often been placed into 2 categories: ischemic and nonischemic cardiomyopathy. The term nonischemic cardiomyopathy has been interchangeably used with DCM. Although this …

Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II

Abstract Aims A non-invasive gene-expression profiling (GEP) test for rejection surveillance of heart transplant recipients originated in the USA. A European-based study, Cardiac Allograft Rejection Gene Expression Observational II Study (CARGO II), was conducted to further clinically validate the GEP test performance. Methods and results Blood samples for GEP testing (AlloMap®, CareDx, Brisbane, CA, USA) were collected during post-transplant surveillance. The reference standard for rejection status was based on histopathology grading of tissue from endomyocardial biopsy. The area under the receiver operating characteristic curve (AUC-ROC), negative (NPVs), and positive predictive values (PPVs) for the GEP scores (range 0–39) were computed. Considering the GEP score of 34 as a cut-off (>6 months post-transplantation), 95.5% (381/399) of GEP tests were true negatives, 4.5% (18/399) were false negatives, 10.2% (6/59) were true positives, and 89.8% (53/59) were false positives. Based on 938 paired biopsies, the GEP test score AUC-ROC for distinguishing ≥3A rejection was 0.70 and 0.69 for ≥2–6 and >6 months post-transplantation, respectively. Depending on the chosen threshold score, the NPV and PPV range from 98.1 to 100% and 2.0 to 4.7%, respectively. Conclusion For ≥2–6 and >6 months post-transplantation, CARGO II GEP score performance (AUC-ROC = 0.70 and 0.69) is similar to the CARGO study results (AUC-ROC = 0.71 and 0.67). The low prevalence of ACR contributes to the high NPV and limited PPV of GEP testing. The choice of threshold score for practical use of GEP testing should consider overall clinical assessment of the patients baseline risk for rejection.

Incidence, predictors, and temporal trends of sudden cardiac death after heart transplantation.

BACKGROUND Sudden cardiac death (SCD) has been reported to be a significant mode of death after heart transplantation (HT) in small case series. However, the incidence, timing, and predictors of SCD have not been examined in a large multicenter HT cohort. OBJECTIVE The purpose of this study was to examine the incidence, timing, predictors, and temporal trends of SCD after HT. METHODS Adults (≥18 years) who underwent first-time HT in the United States between 1987 and 2012 were retrospectively identified from the United Network for Organ Sharing (UNOS) registry. Patients with sudden cardiac arrest as the primary cause of death constituted the SCD group. RESULTS Data on 37,492 HT recipients (mean age 51.9 ± 11.7 years, 77% male, 78% Caucasian) were analyzed. During mean follow-up of 6.5 ± 5.7 years, there were 17,324 (46%) deaths, of which 1659 (9.6%) were SCD. On multivariate Cox regression analysis, left ventricular ejection fraction (LVEF) ≤40% (hazard ratio [HR] 3.67, 95% confidence interval [CI] 3.23-4.17, P < .0001), allograft rejection (HR 1.51, 95% CI 1.35-1.70, P < .0001), and donor age (HR 1.17, 95% CI 1.13-1.23, P < .0001) were associated with increased risk of SCD, whereas recipient age (HR 0.90, 95% CI 0.86-0.95, P < .0001) and Caucasian race (HR 0.61, 95% CI 0.54-0.69, P < .0001) were associated with reduced risk. The incidence of SCD has shown no significant temporal improvement since 1987 (log-rank P = .84). CONCLUSION Approximately 10% of deaths after HT are due to SCD. Allograft rejection and LVEF ≤40% are strong predictors of SCD in adult HT patients. Whether implantable cardioverter-defibrillators would reduce mortality in these patients with a relative higher risk of non-SCD remains to be determined.

Heart Failure in Non-Caucasians, Women, and Older Adults: A White Paper on Special Populations from the Heart Failure Society of America Guideline Committee

The presentation, natural history, clinical outcomes, and response to therapy in patients with heart failure differ in some ways across populations. Women, older adults, and non-Caucasian racial or ethnic groups compose a substantial proportion of the overall heart failure population, but they have typically been underrepresented in clinical trials. As a result, uncertainty exists about the efficacy of some guideline-directed medical therapies and devices in specific populations, which may result in the under- or overtreatment of these patients. Even when guideline-based treatments are prescribed, socioeconomic, physical, or psychologic factors may affect non-Caucasian and older adult patient groups to a different extent and affect the application, effectiveness, and tolerability of these therapies. Individualized therapy based on tailored biology (genetics, proteomics, metabolomics), socioeconomic and cultural considerations, and individual goals and preferences may be the optimal approach for managing diverse patients. This comprehensive approach to personalized medicine is evolving, but in the interim, the scientific community should continue efforts focused on intensifying research in special populations, prescribing guideline-directed medical therapy unless contraindicated, and implementing evidence-based strategies including patient and family education and multidisciplinary team care in the management of patients.

Racial and ethnic disparities in outcomes after heart transplantation: A systematic review of contributing factors and future directions to close the outcomes gap

The demographics of patients undergoing heart transplantation in the United States have shifted over the last 10 years, with an increasing number of racial and ethnic minorities undergoing heart transplant. Multiple studies have shown that survival of African American patients after heart transplantation is lower compared with other ethnic groups. We review the data supporting the presence of this outcome disparity and examine the multiple mechanisms that contribute. With an increasingly diverse population in the United States, knowledge of these disparities, their mechanisms, and ways to improve outcomes is essential.

Pulmonary Arterial Compliance Improves Rapidly after Left Ventricular Assist Device Implantation

Pulmonary artery compliance (PAC) contributes to right ventricular (RV) afterload, is decreased in the setting of increased left ventricular (LV) filling pressures, and may be an important component of World Health Organization (WHO) group II pulmonary hypertension (PH). Left ventricular assist device (LVAD) implantation can rapidly change LV filling, but its relationship with PAC is unknown. Right heart catheterization was performed preoperatively, postoperatively (between 48 and 72 hours), and >30 days post-LVAD implantation in a cohort of 64 patients with end-stage systolic heart failure. Within 72 hours, LVAD implantation was associated with an increase in PAC (2.0—3.7 ml/mm Hg, p < 0.0001), a decrease in pulmonary vascular resistance (3.5—1.7 Wood units, p < 0.0001). Pulmonary arterial compliance did not increase further at the >30 post-LVAD time point (3.7 ± 1.7 to 3.6 ± 0.44 ml/mm Hg, p = 0.44). Pulmonary artery compliance improves rapidly after LVAD implantation. This suggests that more permanent changes in the pulmonary vascular bed may not be responsible for the abnormal PAC observed in WHO group II PH.

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry.

OBJECTIVES The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). BACKGROUND Data on sex differences in outcomes of CS with mechanical circulatory support are sparse. METHODS Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined. RESULTS In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m(2) , P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre-PCI had significantly lower inpatient mortality than those who received support post-PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre-PCI as compared to men. Overall, 68.8% of women survived with pre-PCI Impella 2.5 versus 24.2% post-PCI (P = 0.005) whereas 54.2% of men survived with pre-PCI Impella 2.5 versus 40.3% post-PCI (P = 0.1, p-interaction = 0.07). No differences in timing to intervention were found between men and women. CONCLUSIONS Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248-256).