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Objectives: This study assessed patient and physician perceptions of heart failure (HF) disease severity and treatment options., Background: The prognosis for ambulatory patients with advanced HF on medical therapy is uncertain, yet has important implications for decision making regarding transplantation and left ventricular assist device (LVAD) placement., Methods: Ambulatory patients with advanced HF (New York Heart Association functional class III to IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4 to 7) on optimized medical therapy were enrolled across 11 centers. At baseline, treating cardiologists rated patients for perceived risk for transplant, LVAD, or death in the upcoming year. Patients were also surveyed about their own perceptions of life expectancy and willingness to undergo various interventions., Results: At enrollment, physicians regarded 111 of 161 patients (69%) of the total cohort to be at high risk for transplant, LVAD, or death, whereas only 23 patients (14%) felt they were at high risk. After a mean follow-up of 13 months, 61 patients (38%) experienced an endpoint of 33 deaths (21%), 13 transplants (8%), and 15 LVAD implants (9%). There was poor discrimination between risk prediction among both patients and physicians. Among physician-identified high-risk patients, 77% described willingness to consider LVAD, but 63% indicated that they would decline 1 or more other simpler forms of life-sustaining therapy such as ventilation, dialysis, or a feeding tube., Conclusions: Among patients with advanced HF, physicians identified most to be at high risk for transplantation, LVAD, or death, whereas few patients recognized themselves to be at high risk. Patients expressed inconsistent attitudes toward lifesaving treatments, possibly indicating poor understanding of these therapies. Educational interventions regarding disease severity and treatment options should be introduced prior to the need for advanced therapies such as intravenous inotropic therapy, transplantation, or LVAD., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Many of the 23 million individuals with heart failure (HF) worldwide receive daily, unpaid support from a family member or friend. Although HF and palliative care practice guidelines stipulate that support be provided to family caregivers, the evidence base to guide care for this population has not been comprehensively assessed. In order to appraise the state-of-the-science of HF family caregiving and recommend areas for future research, the aims of this review were to summarize (1) how caregivers influence patients, (2) the consequences of HF for caregivers, and (3) interventions directed at HF caregivers. We reviewed all literature to December 2015 in PubMed and CINAHL using the search terms "heart failure" AND "caregiver." Inclusion criteria dictated that studies report original research of HF family caregiving. Articles focused on children or instrument development or aggregated HF with other illnesses were excluded. We identified 120 studies, representing 5700 caregivers. Research on this population indicates that (1) caregiving situations vary widely with equally wide-ranging tasks for patients to help facilitate their health behaviors, psychological health and relationships, and quality of life (QoL); (2) caregivers have numerous unmet needs that fluctuate with patients' unpredictable medical status, are felt to be ignored by the formal healthcare system, and can lead to distress, burden, and reduced QoL; and (3) relatively few interventions have been developed and tested that effectively support HF family caregivers. We provide recommendations to progress the science forward in each of these areas that moves beyond descriptive work to intervention development and clinical trials testing.

Background: The Cardiac Transplant Research Database (CTRD) collected data from 26 U.S. institutions from January 1, 1990 to December 31, 2008 providing the opportunity for construction of a comprehensive multivariable model of risk for death after transplantation. We analyzed risk factors for death over 19 years of experience to determine how risk profiles have changed over time and how they interact with age., Methods: A multivariable parametric hazard model for death was created for 7,015 patients entered into the CTRD. Variables collected over 19 years of experience were examined as potential risk factors and tested for interaction with date of transplantation to determine if their relative risk (RR) changed over time., Results: The hazard for death post-transplant occurred in 2 phases: an early phase of acute risk lasting <1 year, and a late phase of relatively low, gradually increasing risk (<0.1 event/year). In the early phase, predictive models showed that ventricular assist device (VAD) at the time of transplant did not increase the RR of death for recipient transplant at 30 years of age, but the RR of death was increased by 60% (p = 0.04) at 60 years of age. Of the late-phase variables found to be risk factors, the RR of age, date of transplant and pulmonary vascular resistance changed with respect to transplant year. The overall risk of death dropped importantly over the study period, but the RR of all other variables remained unchanged. RR was 2.6 (p < 0.0001) for 25-year-old African-American (AA) versus non-AA recipients and 1.6 for 60-year-old AA recipients (p = 0.02)., Conclusion: Over 19 years, the baseline risk of death has decreased, but the specific risk factors and the magnitudes of their RR have remained unchanged. Therefore, despite advances in clinical management and improvement in overall survival, the risk profile for death after cardiac transplantation is similar to that in 1990., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients., Background: 30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients., Methods: New York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO2; 6 months only)., Results: Twelve men and 8 women (56.7 ± 7 years, 34 to 71 years of age) with ischemic (n = 7) or nonischemic (n = 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 ± 0.3 to 1.9 ± 0.7, p = 0.0005), MLWHF (63.6 ± 19.9 to 40.2 ± 23.2, p = 0.0005), and KCCQ scores (43.6 ± 21.1 to 65.6 ± 21.5, p = 0.0002), but not 6MWD (275.5 ± 64.0 to 296.4 ± 104.9, p = NS) or pVO2 (14.5 ± 3.6 to 13.1 ± 4.4, p = NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 ± 91.8, p = 0.0425)., Conclusions: Use of C-Pulse in this population is feasible, appears safe, and improves functional status and QoL. A prospective, multicenter, randomized controlled trial is underway. (C-Pulse IDE Feasability Study-A Heart Assist System; NCT00815880)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We discuss a patient with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) who underwent percutaneous coronary intervention and hemodynamic support with a new short-term percutaneously inserted device, the Impella CP (Abiomed). We also review the evidence for mechanical circulatory support and management strategies in patients with AMI-CS.

Cardiac transplantation remains the best treatment option for patients with end-stage, NYHA class IV heart failure who have failed conventional therapy. However, transplant rates have remained static largely due to limited organ donor supplies. Therefore, appropriate allocation of this precious resource is critical to maximize benefit, both at a patient level and at a societal level. Neurologic diseases, such as cerebrovascular disease and peripheral neuropathy, are prevalent in this patient population, as the major risk factors for heart disease place patients at risk for neurologic disease as well. Examples include hypertension, smoking, hypercholesterolemia, obesity, and diabetes. Pretransplant neurologic evaluation is very important to identify conditions that may limit survival after cardiac transplantation. In general, systemic diseases exacerbated by immunosuppression, conditions limiting ability to rehabilitate, and dementias are considered contraindications. Post-transplant neurologic complications are divided into central versus peripheral, and early versus late. The most common early complication is ischemic stroke. Other serious complications include hemorrhagic stroke, encephalopathy, and critical illness neuropathy. Over the long term, post-transplant immunosuppressive regimens are considered "a double edged sword." Although immunosuppressive medications are critical to preventing rejection and allograft dysfunction, they do have significant risk of morbidity and mortality associated with them, including neurologic side-effects. These include: (1) drug toxicities, such as lowering of seizure thresholds; (2) encephalopathy, such as posterior reversible encephalopathy syndrome (PRES); (3) infections; (4) malignancies, such as post-transplant lymphoproliferative disorder (PTLD). Many of the same considerations discussed in adult heart transplant recipients apply to pediatric heart transplant recipients as well. In children, seizures are the most common neurologic complication, although other neurologic complication rates are comparable., (© 2014 Elsevier B.V. All rights reserved.)

Background: This study was conducted to determine the effect of a disease-management model termed an "intensive surveillance protocol" (ISP) on survival in ventricular assist device (VAD) patients. This intervention consisted of a formalized, protocol-driven, multi-disciplinary team approach to VAD patient follow-up initiated August 1, 2006. The goal was to attain an internal program benchmark of 70% survival at 2 years. Historically, 2-year survival after VAD implant has been sub-optimal, and no patient management algorithms have been formally tested to determine their effect on 2-year survival., Methods: The study comprised 76 patients, of whom 26 had a VAD as destination therapy (DT) and 50 as a bridge to transplant (BTT), from July 1, 2003, to June 30, 2008. Survival before and after initiation of ISP was compared. A parametric hazard multivariable analysis, with a time-varying covariable for implementation of ISP, was used to evaluate of other factors affecting survival., Results: Survival at 16 months was 100% for DT patients who received a VAD after August 1, 2006 vs 64% for the earlier era (p = 0.06). For BTT, 16- month survival was 71% vs 43% (p = 0.03). Predicted 2-year survival before and after implementation of the ISP improved from 30% to 87% for DT (p = 0.02) and from 20% to 61% for BTT patients (p = 0.01). Predictors of midterm survival by multivariable analysis included ISP (p = 0.004), younger age (p = 0.03), non-emergent implant (p < 0.0001), and isolated left ventricular VAD (p < 0.0001). After adjustment for covariables, the ISP was associated with a 70% reduction in the hazard for death for the entire cohort (p = 0.004). The effect of ISP was also significant in the patients who received the HeartMate XVE (Thoratec, Pleasanton, CA), which spanned both eras of the study., Conclusions: Survival improved for DT and BTT VAD patients after implementation of the ISP, with a dramatic decrease in hazard for death. Although the transition from pulsatile to axial flow technology occurred during the study period and likely contributed to improved outcomes, the institution of the ISP provided an important and significant contribution to improved survival through a proactive approach to patient management, allowing earlier identification of potential adverse events. For optimal outcomes, VAD patients require intensive follow-up surveillance protocols that have previously become standard in the care of heart transplant patients., (Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: The use of large, pulsatile left ventricular assist devices (LVADs) has been limited in women because of their small body size., Methods: We compared the survival outcomes, quality of life, and adverse events in 465 patients (104 women, 361 men) with advanced systolic heart failure in their first 18 months of support with the HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow LVAD for bridge to transplantation., Results: During the first 18 months, there were no differences in survival between women and men while on LVAD support (73% ± 3% vs 73% ± 5%, p = 0.855) but fewer women (40%) underwent heart transplantation than did men (55%; p = 0.001). More women continued on support after 18 months (p = 0.007). Median duration of support was 238 days for women and 184 days for men (p = 0.003). Mortality was 20% for women and 19% for men (p = 0.89). Adverse events were similar, with the exception of hemorrhagic stroke, which occurred more frequently in women (0.10 vs 0.04 events/patient-year, p = 0.02), and device-related infections, which occurred less frequently in women (0.23 vs 0.44, p = 0.006). Functional capacity and quality of life at 6 months improved significantly in women and men., Conclusions: Continuous-flow left ventricular assistance as a bridge to transplantation is associated with similar survival rates in women and men. Differences observed in higher stroke rates and fewer infections among women require further study., (Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Implantable hemodynamic monitoring to guide heart failure (HF) therapy is a promising area of active research. The goal of this investigation was to evaluate the safety and technical performance of a novel wireless pulmonary artery pressure monitoring system in 17 patients with symptomatic HF., Methods: The monitoring system consists of a sensor, delivery catheter, interrogator, and home monitoring device. The HF sensor was implanted into a distal branch of the pulmonary artery. Pulmonary artery pressures were monitored using the external device, which powers the HF sensor and transmits the hemodynamic data from the patient's home to a secure Internet database. The accuracy of the system was assessed by comparison with standard right heart catheterization (RHC)., Results: The HF sensor was safely and successfully implanted in all patients. Agreement between the HF sensor and RHC for systolic, diastolic, and mean pulmonary artery pressures was excellent, with correlation coefficients of 0.94, 0.85, and 0.95, respectively (all P < .0001). Using Bland-Altman plots, the average differences for systolic, diastolic, and mean pulmonary artery pressures for the HF sensor vs RHC were -4.4 ± 0.3, 2.5 ± 1.0, and -0.8 ± 1.3 mm Hg, respectively. There were no serious device-related adverse events. A postmortem analysis of the HF sensor in a patient who died 12 months after implant demonstrated complete endothelialization and no evidence of thrombosis., Conclusions: This trial supports the safety and accuracy of this pulmonary artery pressure monitoring system in patients with HF and the conduct of randomized trials of implantable hemodynamic monitoring in HF, using this system., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Background: Donor and recipient risk factors for rejection and infection have been well characterized. The contribution of demographic factors, especially age at the time of transplantation to morbidity and mortality due to rejection and infection, is much less well understood., Methods: Using parametric hazard analysis and multivariate risk-factor equations for infection and rejection events, we quantitatively determined the relationship of fundamental demographic variables (age, race and gender) to infection and rejection. These analyses were conducted with respect to date of transplant and age at the time of transplantation. The patient group consisted of all primary heart transplants performed at the University of Alabama at Birmingham during the years 1990 to 2007 (n = 526)., Results: Risk factors for rejection within 12 months post-transplantation were date of transplant (p < 0.0001) and age at the time of transplantation (young adults 10 to 30 years of age, p < 0.0001). Risk factors for infection were date of transplant (p < 0.0001) and age at the time of transplantation (young children and older adults, p < 0.0001). There were three immunosuppressive eras in 1990 to 2007. Notably, although the proportion of patients experiencing rejection and infection events decreased during each successive immunosuppressive era, the relative relationship of infection to rejection, as well as age at the time of transplantation, remained similar into the most recent era. The maximal frequency of rejection events and rejection death occurred among patients transplanted at ages 10 to 30 years. Conversely, the frequency of infection events was minimal within the same group. In the oldest and youngest patients receiving transplants, infection was the predominant cause of death and rates of rejection events decreased., Conclusions: These data show that evolving immunosuppressive strategies have successfully reduced rejection and infection frequencies, and those patients transplanted at 30 to 60 years of age have the lowest frequency of rejection/infection events. However, individuals transplanted at younger or older ages, especially non-white recipients in the 10- to 30-year age group, experience significantly more infection or rejection. Therefore, programs should increase the level of surveillance in these patients and consider modification of immunosuppressive regimens in order to lower the frequency of infection and rejection events., (Copyright 2010 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Context: Treatment disparities for socioeconomically disadvantaged populations have been widely reported, but few studies have sought explanations for these disparities., Objective: To compare the quality of care for patients insured by Medicare alone, Medicare plus Medicaid, or Medicare plus private insurance and investigate mediators for potential disparities., Design, Setting, and Participants: Retrospective, random chart review of 3122 African American or White Medicare patients >65 years of age hospitalized for unstable angina in 22 Alabama hospitals, 1993-1999., Main Outcome Measures: Echocardiogram within 20 minutes of presentation; evaluation by a cardiologist; appropriate anti-platelet therapy within 24 hours of admission and at discharge, heparin for high-risk patients, beta-blockers during hospitalization, and performance of appropriate coronary angiography., Results: 182 (5.8%) had Medicare only, 433 (13.9%) had Medicare plus Medicaid, and 2507 (80.3%) had Medicare plus private insurance. Medicaid patients were more frequently Black, female, >85 years old, had multiple co-morbidities, or were admitted to hospitals without cardiac catheterization facilities (P<.001). Fewer Medicaid patients were admitted to hospitals with cardiac catheterization capabilities. Even after adjustment for demographics and hospital characteristics, Medicaid patients were less likely to see a cardiologist (odds ratio [OR] .57, 95% confidence interval [CI] .44-.73), receive antiplatelet therapy within 24 hours of admission (OR .66, 95% CI .50-.87), or heparin (OR .71, 95% CI .53-.97). No differences were seen with regard to having an electrocardiogram within 20 minutes of admission. Beta-blockers were used least in the Medicare-only patients, with only 37.7% receiving them (P=.04). Suitable Medicaid patients received coronary angiography less often, even after adjustment for demographics, co-morbidity, and prior revascularization (OR .68, 95% CI .48-.97). However, when adjusted for hospital characteristics, this finding was no longer observed (OR .94, 95% CI .64-1.39)., Conclusions: Elderly Medicaid patients appear to receive poorer quality of care. This finding is partially, but not completely, explained by characteristics of the facilities where they are hospitalized.