[New Treatment Strategies in Patients with Heart Failure with Reduced Ejection Fraction: Beyond Neurohormonal Inhibition].

Patients affected by heart failure (HF) with reduced ejection fraction (HFrEF) are prone to experience episodes of worsening symptoms and signs despite continued therapy, termed "worsening heart failure" (WHF). Although guideline-directed medical therapy is well established, worsening of chronic heart failure accounts for almost 50% of all hospital admissions for HF with consequent higher risk of death and hospitalization than patients with "stable" HF. New drugs are emerging as cornerstones to reduce residual risk of both cardiovascular mortality and readmission for heart failure. The following review will debate about emerging definition of WHF in light of the recent clinical consensus released by the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) and the new therapeutic strategies in cardiorenal patients.

Aortic pulse wave analysis and functional capacity of heart transplantation candidates: a pilot study.

We compared cardiovascular parameters obtained with the Mobil-O-Graph and functional capacity assessed by the Duke Activity Status Index (DASI) before and after Heart Transplantation (HT) and also compared the cardiovascular parameters and the functional capacity of candidates for HT with a control group. Peripheral and central vascular pressures increased after surgery. Similar results were observed in cardiac output and pulse wave velocity. The significant increase in left ventricular ejection fraction (LVEF) postoperatively was not followed by an increase in the functional capacity. 24 candidates for HT and 24 controls were also compared. Functional capacity was significantly lower in the HT candidates compared to controls. Stroke volume, systolic, diastolic, and pulse pressure measured peripherally and centrally were lower in the HT candidates when compared to controls. Despite the significant increase in peripheral and central blood pressures after surgery, the patients were normotensive. The 143.85% increase in LVEF in the postoperative period was not able to positively affect functional capacity. Furthermore, the lower values of LVEF, systolic volume, central and peripheral arterial pressures in the candidates for HT are consistent with the characteristics signs of advanced heart failure, negatively impacting functional capacity, as observed by the lower DASI score.

Self-care behavior and associated factors among adult heart failure patients in outpatient cardiac follow-up unit at Wachemo University Nigist Eleni Comprehensive Specialized Hospital, Southern Ethiopia.

BACKGROUND: Heart failure is a serious medical condition that occurs when the heart is unable to pump sufficient blood to meet the needs of the tissues. Good self-care is an essential behavior in long term management and maintenance of physiologic stability, better medical and person-centered outcomes. Poor self-care behavior deteriorates the outcomes of heart failure patients. However, there were no sufficient evidences that illustrate the topic in the country, including the study area. METHODOLOGY: Institutional based cross-sectional study was conducted among 250 heart failure patients from July 5-August 4, 2021. All adult heart failure patients who fulfill the inclusion criteria and have appointment during study period were included in the study. Interview and medical chart review was used to collect data. Epidata version 3.1 and SPSS version 20 were used for data entry and analysis respectively. Bivariate and multivariable analysis was computed. The model fitness was checked by Hosmer and Lemeshow test. RESULTS: From the total patients, 240 were interviewed with the response rate of 96%. Among these, 140(58.3%) [95% CI: 52.6, 64.9] had poor self-care behavior. Age>54: 9.891 [2.228, 43.922], poor knowledge: 6.980[1.065, 45.727], depression: 4.973[1.107, 22.338], low social support: 6.060[1.373, 26.739], insomnia: 4.801[1.019, 22.622] and duration with heart failure <1 year: 5.782[1.438, 23.247] were factors associated with poor self-care behavior. CONCLUSION: In this study, more than half of participants attending at Wachemo University Nigist Eleni Comprehensive Specialized Hospital in outpatient cardiac follow-up unit had poor self-care behavior. Of the study variables, older age, poor knowledge, depressive symptoms, low social support, insomnia and short duration with heart failure were related with poor self-care behavior. Thus, the findings highlight importance of assessing level of self-care behavior and implicate direction to take action to enhance level of self-care behavior.

[Ten questions about cardiopulmonary exercise testing: all that the cardiologist dares or dares not to ask]. / Dieci quesiti in tema di test da sforzo cardiopolmonare: tutto quello che il cardiologo osa e non osa chiedere.

In patients with cardiovascular, pulmonary, muscular and neurological diseases, cardiopulmonary exercise testing (CPET) is a valuable tool providing clinically-relevant diagnostic and prognostic information by evaluation of exercise response. CPET requires to be performed in dedicated centers able to correctly carry out the examination and to carefully evaluate the results. CPET analyzes functional capacity revealing both symptomatic and asymptomatic intolerance to exercise. One of the most important advantages for clinicians derived by the use of CPET, beyond standard exercise electrocardiography testing, is the capability not only to grade the severity of the disease, but also to distinguish between different causes of dyspnea and exercise impairment. Indications for CPET use in clinical practice are increasing in the last decades, evolving beyond the routine use as a training tool in athletes. In fact, CPET represents an important step in the management of patients with heart failure or pulmonary hypertension, as suggested by international guidelines. CPET role in helping for the selection of patients candidate to heart transplantation is also well known. Beyond its clinical usefulness, scientific interest in CPET is constantly expanding, mainly due to the safety of the exam and to the huge size of the pathophysiological information that it offers. The aim of this paper is to simply explain everyday applications and potential further purposes of CPET in clinical practice. Our review is intended both for physicians approaching CPET for the first time and for clinicians with an interest in expanding their knowledge in this field.

[New perspectives in the diagnosis and treatment of heart failure with preserved ejection fraction (HFpEF)]. / Avancées dans le diagnostic et traitement de l'insuffisance cardiaque à fraction d'éjection préservée.

Heart failure with preserved ejection fraction (HFpEF), defined as ≥50 %, affects 1 to 3 % of the population and represents a diagnostic challenge. Clinical scores have been developed to facilitate the diagnosis of affected patients, who can now benefit from new treatments. Recent studies have shown a reduction in cardiovascular morbidity and mortality with sodium-glucose cotransporter-2 (SGLT-2) inhibitors in this population. Other promising drugs, currently in the study phase, could potentially change the management approach in the near future. Finally, controlling symptoms, signs of congestion and the frequently encountered comorbidities in this population remain crucial.

L'insuffisance cardiaque à fraction d'éjection préservée (HFpEF), soit ≥ 50 %, touche 1 à 3 % de la population et représente un défi diagnostique. Des scores cliniques ont été développés pour faciliter l'identification des patients concernés qui peuvent désormais bénéficier de nouveaux traitements. Des études récentes ont en effet montré une diminution de la morbimortalité cardiovasculaire grâce aux inhibiteurs du cotransporteur sodium-glucose de type 2 (iSGLT2) dans cette population. D'autres médicaments prometteurs actuellement en phase d'étude pourraient aussi changer la prise en charge dans un futur proche. Enfin, le contrôle des symptômes et signes de congestion ainsi que le traitement des comorbidités fréquemment rencontrées dans cette population restent essentiels.

Clinical characteristics, treatment patterns, and outcomes of hospitalized patients with acute heart failure in central Ethiopia: a retrospective observational study.

BACKGROUND: Acute heart failure is the rapid onset of new or worsening symptoms and signs of heart failure. Despite the increasing burden of heart failure in developing countries like Ethiopia, there is a paucity of comprehensive data regarding the clinical characteristics, treatment patterns, and outcomes of acute heart failure, especially in the selected study area. Therefore, this study aimed to assess the clinical characteristics, treatment patterns, and outcomes of hospitalized patients with acute heart failure at Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia. METHODS: This is a retrospective cross-sectional study of 303 acute heart failure patients who were admitted to the medical wards and intensive care unit of Yekatit 12 Hospital Medical College, Addis Ababa, central Ethiopia, from July 1, 2022, to July 1, 2023. A pretested data abstraction format was used for data extraction from electronic medical records, and SPSS version 26 was used for data analysis. Descriptive analysis was used to summarize sociodemographic data, clinical characteristics, treatment patterns, and outcomes of acute heart failure. Bivariate and multivariate logistic regression models were fitted to identify factors associated with in-hospital mortality. The odds ratio (OR) with the corresponding 95% confidence interval (CI) was calculated to show the strength of the association. RESULTS: Of the 303 patients, 51.5% were females, and the mean age was 56.7 years. The most frequent symptom and sign were dyspnea (98.7%) and peripheral edema (79%), respectively. The commonest underlying cause and precipitating factor of acute heart failure were cor pulmonale (22.8%) and pneumonia (35.3%), respectively. The commonest anti-remodeling medications prescribed on discharge were beta-blockers (47.9%), followed by mineralocorticoid receptor antagonists (42.8%) and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (38.6%), and the least prescribed were sodium-glucose cotransporter 2 inhibitors (8.3%). The in-hospital mortality rate was 8.6%, and the median length of hospital stay was 9 days. Based on the multivariate logistic regression analysis, the most important predictors of in-hospital mortality were systolic blood pressure (SBP) < 115 mmHg (adjusted odds ratio [AOR] = 6.28; 95% CI: 1.99, 19.78), chloride level < 96 mg/dL (AOR = 4.88; 95% CI: 1.30, 18.33), blood urea nitrogen (BUN) > 20 mg/dl (AOR = 5.48; 95% CI: 1.47, 20.49), and presence of dyslipidemia (AOR = 3.73, 95% CI: 1.15, 12.07). CONCLUSIONS: This study has shown that systolic blood pressure (SBP) < 115 mmHg, blood urea nitrogen (BUN) > 20 mg/dL, chloride (Cl) level < 96 mg/dL, and the presence of dyslipidemia were statistically significant factors associated with in-hospital mortality among patients with acute heart failure. Hence, healthcare providers should stratify patients with acute heart failure upon admission based on their risk of in-hospital mortality and address those potential negative prognostic indicators accordingly.

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. METHODS AND ANALYSIS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. DISCUSSION: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. TRIAL REGISTRATION: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.

[Heart failure with preserved left ventricular ejection fraction (HFpEF)].

INTRODUCTION: Heart failure with preserved left ventricular ejection fraction (HFpEF) is a common and very important disease entity because of its association with frequent repeat hospitalization and high mortality. Hallmarks of the underlying pathophysiology include a small left ventricular cavity due to concentric remodeling, impaired left ventricular compliance and left atrial dysfunction. This leads to an increase in left atrial and pulmonary pressure on exertion and in advanced stages of the disease already at rest with consecutive exertional dyspnea and exercise intolerance. Additional cardiovascular mechanisms including atrial fibrillation, chronotropic incompetence and coronary artery disease as well as non-cardiac co-morbidities contribute to a variable extent to the clinical picture. The diagnostic work-up is demanding and complex but the concepts have significantly improved during the last years. The study results of the Sodium Glucose cotransporter-2 inhibitors (SGLT-2-inhibitors) have revolutionized the treatment of HFpEF. In the present article, we provide an overview about the current understanding of the pathophysiology of HFpEF, the principles of the diagnostic pathways and a summary of the intervention studies in the field, and we propose an approach for the treatment in clinical practice.

[Heart failure with reduced left ventricular ejection fraction (HFrEF, HFmrEF)].

INTRODUCTION: Heart failure is the final stage of most heart diseases and, with over 64 million people affected worldwide, is considered a global pandemic. The prevalence is expected to continue to rise. The prevention and treatment of cardiovascular diseases and the early detection of patients suffering from heart failure are essential. Different therapies are available depending on the extent of the reduction in left ventricular ejection fraction (LVEF). Optimal treatment prevents unnecessary admissions to hospital, reduces mortality and improves quality of life. In the following article, we discuss the diagnosis of heart failure and explain the various treatment options for heart failure with reduced LVEF (HFrEF, HFmrEF).

Mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction: a systematic review and network meta-analysis of 32 randomized trials.

INTRODUCTION: Several randomized controlled trials (RCTs) have examined mineralocorticoid receptor antagonists (MRAs) in heart failure (HF) with reduced ejection fraction (HFrEF). This systematic review and network meta-analysis (NMA) evaluated the comparative efficacy and safety of MRAs in HFrEF. MATERIALS AND METHODS: MEDLINE(Pubmed), Scopus, Cochrane and ClinicalTrials.gov were searched until April 8, 2024 for RCTs examining the efficacy and/or safety of MRAs in HFrEF. Double-independent study selection, extraction and quality assessment were performed. Random-effects frequentist NMA models were used. Evidence certainty was assessed via Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Totally, 32 RCTs (15685 patients) were analyzed. Eplerenone ranked above spironolactone in all-cause mortality (hazard ratio {HR}=0.78, 95% confidence interval {CI} [0.66,0.91], GRADE:"Moderate"), cardiovascular death (HR=0.74, 95%CI [0.53, 1.04], GRADE:"Low") and in all safety outcomes. Spironolactone was superior to eplerenone in the composite of cardiovascular death or hospitalization (HR=0.67, 95%CI [0.50,0.89], GRADE:"Moderate"), HF hospitalization (HR=0.61, 95%CI [0.43,0.86], GRADE:"Moderate"), all-cause hospitalization (HR=0.51, 95%CI [0.26,0.98], GRADE:"Moderate") and cardiovascular hospitalization (HR=0.56, 95%CI [0.37,0.84], GRADE:"Moderate"). Canrenone ranked first in all-cause mortality, the composite outcome and HF hospitalization. Finerenone ranked first in hyperkalemia (risk ratio [RR]=1.56, 95%CI [0.89,2.74], GRADE:"Moderate"), renal injury (RR=0.56, 95%CI [0.24,1.29]), any adverse event (RR=0.84, 95%CI [0.75,0.94], GRADE:"Moderate"), treatment discontinuation (RR=0.89, 95%CI [0.64,1.23]) and hypotension (RR=1.06, 95%CI [0.12,9.41]). CONCLUSIONS: MRAs are effective in HFrEF with certain safety disparities. Spironolactone and eplerenone exhibited similar efficacy, however, eplerenone demonstrated superior safety. Finerenone was the safest MRA, while canrenone exhibited considerable efficacy, nonetheless, evidence for these MRAs were scarce.

A review regarding the article 'Effectiveness of mechanical circulatory support devices in reversing pulmonary hypertension among heart transplant candidates: A systematic review.'

Pulmonary hypertension (PH) with high pulmonary vascular resistance (PVR) is a very often diagnosed contraindication for orthotopic heart transplantation (OHT). It is a direct consequence of left ventricle failure characterized by high diastolic pressure obstructing the collection of blood from the pulmonary vessels. The occurrence of this situation grows with the increasing time of waiting for OHT, and with the progression of heart failure. Mechanical circulatory support (MCS) devices, particularly left ventricular assist devices (LVADs), have emerged as pivotal interventions for patients with fixed PH, offering a potential bridge to transplantation. The pathophysiological impact of PH in heart transplant candidates is profound, as it is associated with increased perioperative risk and heightened mortality post-transplantation. The selection of heart transplant candidates thus mandates a careful evaluation of PH, with an emphasis on distinguishing between reversible and fixed forms of the condition. Reversible PH can often be managed with medical therapies; however, fixed PH presents a more daunting challenge, necessitating more aggressive interventions like MCS. Patients are supported with LVADs until evidence of pulmonary afterload reversal is evident and then can be considered for heart transplantation. However, in those who are non-responders or have complications while being supported, their option for transplant is revoked. Despite these advancements, the heterogeneity of MCS devices and their mechanisms of action necessitates a nuanced understanding of their efficacy.

A hierarchical kidney outcome using win statistics in patients with heart failure from the DAPA-HF and DELIVER trials.

Win statistics offer a new approach to the analysis of outcomes in clinical trials, allowing the combination of time-to-event and longitudinal measurements and taking into account the clinical importance of the components of composite outcomes, as well as their relative timing. We examined this approach in a post hoc analysis of two trials that compared dapagliflozin to placebo in patients with heart failure and reduced ejection fraction (DAPA-HF) and mildly reduced or preserved ejection fraction (DELIVER). The effect of dapagliflozin on a hierarchical composite kidney outcome was assessed, including the following: (1) all-cause mortality; (2) end-stage kidney disease; (3) a decline in estimated glomerular filtration rate (eGFR) of ≥57%; (4) a decline in eGFR of ≥50%; (5) a decline in eGFR of ≥40%; and (6) participant-level eGFR slope. For this outcome, the win ratio was 1.10 (95% confidence interval (CI) = 1.06-1.15) in the combined dataset, 1.08 (95% CI = 1.01-1.16) in the DAPA-HF trial and 1.12 (95% CI = 1.05-1.18) in the DELIVER trial; that is, dapagliflozin was superior to placebo in both trials. The benefits of treatment were consistent in participants with and without baseline kidney disease, and with and without type 2 diabetes. In heart failure trials, win statistics may provide the statistical power to evaluate the effect of treatments on kidney as well as cardiovascular outcomes.

Obesity and heart failure with preserved ejection fraction.

OBJECTIVE: Aim: To perform an overall assessment of heart failure with preserved ejection fraction (HFpEF) adults with central obesity. PATIENTS AND METHODS: Materials and Methods: We enrolled HFpEF patients with central obesity (n =73, mean age 52.4 ± 6.3 years) and without obesity (n =70, mean age 51.9 ± 7.1 years) and compared with an age-matched healthy subjects who had not suffered from HF (n = 69, mean age 52.3 ± 7.5 years). Physical examination, routine laboratory tests such as fasting blood glucose, fasting insulin, insulin resistance (HOMA) index, serum lipids, haemoglobin, creatinine, ALT, AST, uric acide, hs CRP, TSH, N-terminal proB-type natriuretic peptide (NT-proBNP) and standard transthoracic echocardiogram (2D and Doppler) examinations were performed and assessed. RESULTS: Results: The average values of diastolic blood pressure (DBP), glucose and lipid profiles, uric acide, hs CRP were found to be significantly higher among obese patients with HFpEF than non-obese. Despite more severe symptoms and signs of HF, obese patients with HFpEF had lower NT-proBNP values than non-obese patients with HFpEF (129±36.8 pg/ml, 134±32.5 pg/ml vs 131±30.4 pg/ml, 139±33.8 pg/ml respectively; p < 0.05). However, it was found that patients with high central (visceral) adiposity have more pronounced obesity-related LV diastolic dysfunction, lower E/e' ratio, lower mitral annular lateral e' velocity, an increased LV diastolic dimension and LV mass index. Compared with non-obese HFpEF and control subjects, obese patients displayed greater right ventricular dilatation (base, 35±3.13 mm, 36±4.7 mm vs 33±2.8 mm, 34±3.2 mm and 29±5.3 mm, 30±3.9 mm; length, 74±5 mm, 76±8 mm vs 67±4 mm, 69±6 mm and 60±3 mm, 61±5 mm respectively; p < 0.05), more right ventricular dysfunction (TAPSE 16±2 mm, 15±3 mm vs 17±2 mm, 17±1 mm and 19±2 mm, 20±3 mm respectively; p < 0.05). CONCLUSION: Conclusions: Obese patients with HFpEF have higher diastolic BP, atherogenic dyslipidemia, insulin resistance index values and greater systemic inflammatory biomarkers, despite lower NT-proBNP values, which increase the risk of cardiovascular events in future. Echocardiography examination revealed not only significant LV diastolic dysfunction, but also displayed greater RV dilatation and dysfunction.

Accidental Conduction System Pacing in Patient with Displaced Cardiac Resynchronization Therapy Leads.

A 69-year-old woman with a history of heart failure with reduced ejection fraction presented for device interrogation of her cardiac implantable electronic device (CIED), revealing lead and pulse generator displacement. Surprisingly, she exhibited a narrow QRS on the ECG despite an underlying right bundle branch block, suggesting unintentional conduction system pacing (CSP). Traditional cardiac resynchronization therapy has been widely used for patients with heart failure, but alternatives like CSP are emerging as viable options. Given the global rise in CIED utilization, regular follow-up, device troubleshooting, and embracing remote monitoring are essential to manage and optimize patient outcomes.

Evaluating the impact of Sacubitril/valsartan on diastolic function in patients with heart failure: A systematic review and meta-analysis.

BACKGROUND: Heart failure is a common and severe condition, often complicated by diastolic dysfunction. Current standard therapies such as ACEIs and ARBs have limited efficacy in managing diastolic function. Sacubitril/Valsartan, an emerging therapy, warrants rigorous investigation to elucidate its impact on diastolic function in heart failure patients. METHODS: This systematic review and meta-analysis were conducted adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and utilized the PICO schema. Searches were performed on 4 databases-PubMed, Embase, Web of Science, and Cochrane Library-without temporal restrictions. Inclusion and exclusion criteria were strictly defined, and quality assessments were conducted using the Cochrane Collaboration Risk of Bias tool. Both fixed-effects and random-effects models were used for statistical analysis, depending on inter-study heterogeneity assessed by I2 statistics and Chi-square tests. RESULTS: Out of 1129 identified publications, 8 studies met the criteria and were included in the meta-analysis. These studies consisted of both randomized controlled trials and cohort studies and featured diverse global populations. Significant reductions were found in the echocardiographic parameter E/e' ratio and LAVi upon treatment with Sacubitril/Valsartan compared to standard therapies, with mean differences of -1.38 and -4.62, respectively, both with P values < .01. CONCLUSIONS: This meta-analysis demonstrates that Sacubitril/Valsartan significantly improves diastolic function parameters in heart failure patients compared to standard treatments. These findings underscore the potential benefits of Sacubitril/Valsartan in the management of heart failure, particularly for patients with diastolic dysfunction.

MEMS Technology in Cardiology: Advancements and Applications in Heart Failure Management Focusing on the CardioMEMS Device.

Heart failure (HF) is a complex clinical syndrome associated with significant morbidity, mortality, and healthcare costs. It is characterized by various structural and/or functional abnormalities of the heart, resulting in elevated intracardiac pressure and/or inadequate cardiac output at rest and/or during exercise. These dysfunctions can originate from a variety of conditions, including coronary artery disease, hypertension, cardiomyopathies, heart valve disorders, arrhythmias, and other lifestyle or systemic factors. Identifying the underlying cause is crucial for detecting reversible or treatable forms of HF. Recent epidemiological studies indicate that there has not been an increase in the incidence of the disease. Instead, patients seem to experience a chronic trajectory marked by frequent hospitalizations and stagnant mortality rates. Managing these patients requires a multidisciplinary approach that focuses on preventing disease progression, controlling symptoms, and preventing acute decompensations. In the outpatient setting, patient self-care plays a vital role in achieving these goals. This involves implementing necessary lifestyle changes and promptly recognizing symptoms/signs such as dyspnea, lower limb edema, or unexpected weight gain over a few days, to alert the healthcare team for evaluation of medication adjustments. Traditional methods of HF monitoring, such as symptom assessment and periodic clinic visits, may not capture subtle changes in hemodynamics. Sensor-based technologies offer a promising solution for remote monitoring of HF patients, enabling early detection of fluid overload and optimization of medical therapy. In this review, we provide an overview of the CardioMEMS device, a novel sensor-based system for pulmonary artery pressure monitoring in HF patients. We discuss the technical aspects, clinical evidence, and future directions of CardioMEMS in HF management.

A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure.

BACKGROUND: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. METHODS: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. RESULTS: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. CONCLUSION: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497).