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1.
Cell Transplant ; 33: 9636897241248956, 2024.
Article in English | MEDLINE | ID: mdl-38715279

ABSTRACT

Heart failure remains the leading cause of human death worldwide. After a heart attack, the formation of scar tissue due to the massive death of cardiomyocytes leads to heart failure and sudden death in most cases. In addition, the regenerative ability of the adult heart is limited after injury, partly due to cell-cycle arrest in cardiomyocytes. In the current post-COVID-19 era, urgently authorized modified mRNA (modRNA) vaccines have been widely used to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Therefore, modRNA-based protein replacement may act as an alternative strategy for improving heart disease. It is a safe, effective, transient, low-immunogenic, and integration-free strategy for in vivo protein expression, in addition to recombinant protein and stem-cell regenerative therapies. In this review, we provide a summary of various cardiac factors that have been utilized with the modRNA method to enhance cardiovascular regeneration, cardiomyocyte proliferation, fibrosis inhibition, and apoptosis inhibition. We further discuss other cardiac factors, modRNA delivery methods, and injection methods using the modRNA approach to explore their application potential in heart disease. Factors for promoting cardiomyocyte proliferation such as a cocktail of three genes comprising FoxM1, Id1, and Jnk3-shRNA (FIJs), gp130, and melatonin have potential to be applied in the modRNA approach. We also discuss the current challenges with respect to modRNA-based cardiac regenerative medicine that need to be overcome to apply this approach to heart disease. This review provides a short description for investigators interested in the development of alternative cardiac regenerative medicines using the modRNA platform.


Subject(s)
Myocytes, Cardiac , RNA, Messenger , Regeneration , Humans , Myocytes, Cardiac/metabolism , Myocytes, Cardiac/cytology , Animals , RNA, Messenger/genetics , RNA, Messenger/metabolism , COVID-19/therapy , SARS-CoV-2/genetics , Heart Failure/therapy
2.
Kardiologiia ; 64(4): 31-37, 2024 Apr 30.
Article in Russian, English | MEDLINE | ID: mdl-38742513

ABSTRACT

AIM: Identification of clinical and instrumental predictors for non-arrhythmic death in patients with heart failure (HF) and implantable cardioverter-defibrillator (ICD). MATERIAL AND METHODS: Through a telephone survey and examination of medical records from hospital and polyclinic databases, data were obtained on the alive/dead status and causes of death for 260 patients with heart failure (HF) and ICD included in the Kuzbass Registry of Patients with ICD. The follow-up period was 1.5 years. Clinical and instrumental parameters entered into the registry before the ICD implantation were included in a univariate and multivariate step-by-step analysis using the logistic (for qualitative variables) and linear (for quantitative variables) regression with calculation of regression coefficients and construction of a prognostic regression model. The quality of the created model was assessed using a ROC analysis. RESULTS: During the observation period, 54 (20.8%) patients died. In 21 (38.8%) patients, death occurred in the hospital and was caused by acute decompensated heart failure in 15 (71.4%) patients, myocardial infarction in 3 (14.3%) patients, stroke in 1 (4.7%) patient, and pneumonia in 2 (9.5%) patients. 33 (61.2%) patients died outside the hospital; the cause of death was stated as the underlying disease associated with acute decompensated heart failure: in 9 (27.2%) patients, dilated cardiomyopathy; in 1 (3.0%) patient, rheumatic mitral disease; and in 23 (69.7%) patients, ischemic cardiomyopathy. According to the univariate regression model, the risk of death in the long-term period was increased by the QT interval prolongation (U 2.41, p = 0.0161); elevated pulmonary artery systolic pressure (U 4.30, p=0.0000) and increased left atrial size according to echocardiography (U 2.98, p=0.0029); stage IIB HF (OR 2.41; 95% CI: 1.26-4.6), NYHA III-IV (OR 3.03; 95% CI: 1.58-5.81); chronic obstructive pulmonary disease (OR 5.24; 95% CI: 2.04-13.45); and lack of optimal drug therapy (ODT) for HF before ICD implantation (OR 2.41; 95% CI: 1.29-4.49). The multivariate analysis identified the most significant factors included in the prognostic regression model: pulmonary artery systolic pressure above 45 mm Hg, social status, chronic obstructive pulmonary disease, and lack of ODT for HF. CONCLUSION: To ensure a maximum benefit from ICD, the factors that increase the likelihood of non-arrhythmic death should be considered before making a decision on ICD implantation. Particular attention should be paid to mandatory ODT for HF as the main modifiable risk factor for unfavorable prognosis.


Subject(s)
Defibrillators, Implantable , Heart Failure , Registries , Humans , Heart Failure/physiopathology , Heart Failure/therapy , Female , Male , Prognosis , Middle Aged , Aged , Prospective Studies , Russia/epidemiology , Cause of Death/trends , Risk Factors
4.
BMC Cardiovasc Disord ; 24(1): 238, 2024 May 07.
Article in English | MEDLINE | ID: mdl-38714943

ABSTRACT

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.


Subject(s)
Heart Failure , Self Care , Humans , Ethiopia/epidemiology , Heart Failure/therapy , Heart Failure/diagnosis , Heart Failure/physiopathology , Heart Failure/psychology , Female , Male , Cross-Sectional Studies , Middle Aged , Aged , Adult , Risk Factors , Health Behavior , Health Knowledge, Attitudes, Practice , Ambulatory Care , Time Factors , Hospitals, University
5.
Curr Heart Fail Rep ; 21(3): 238-251, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38696059

ABSTRACT

PURPOSE OF THE REVIEW: Cancer therapy-related cardiac dysfunction (CTRCD) has been identified as a threat to overall and cancer-related survival. Although aerobic exercise training (AET) has been shown to improve cardiorespiratory fitness (CRF), the relationship between specific exercise regimens and cancer survival, heart failure development, and reduction of CTRCD is unclear. In this review, we discuss the impact of AET on molecular pathways and the current literature of sports in the field of cardio-oncology. RECENT FINDINGS: Cardio-oncological exercise trials have focused on variations of AET intensity by using moderate continuous and high intensity interval training, which are applicable, safe, and effective approaches to improve CRF. AET increases CRF, reduces cardiovascular morbidity and heart failure hospitalization and should thus be implemented as an adjunct to standard cancer therapy, although its long-term effect on CTRCD remains unknown. Despite modulating diverse molecular pathways, it remains unknown which exercise regimen, including variations of AET duration and frequency, is most suited to facilitate peripheral and central adaptations to exercise and improve survival in cancer patients.


Subject(s)
Exercise Therapy , Exercise , Neoplasms , Humans , Neoplasms/therapy , Exercise Therapy/methods , Exercise/physiology , Cardiorespiratory Fitness/physiology , Heart Failure/therapy , Heart Failure/physiopathology
6.
JACC Heart Fail ; 12(5): 902-904, 2024 May.
Article in English | MEDLINE | ID: mdl-38719387
8.
Crit Care Explor ; 6(5): e1082, 2024 May.
Article in English | MEDLINE | ID: mdl-38694845

ABSTRACT

OBJECTIVES: To evaluate the relationship between early IV fluid volume and hospital outcomes, including death in-hospital or discharge to hospice, in septic patients with and without heart failure (HF). DESIGN: A retrospective cohort study using logistic regression with restricted cubic splines to assess for nonlinear relationships between fluid volume and outcomes, stratified by HF status and adjusted for propensity to receive a given fluid volume in the first 6 hours. An ICU subgroup analysis was performed. Secondary outcomes of vasopressor use, mechanical ventilation, and length of stay in survivors were assessed. SETTING: An urban university-based hospital. PATIENTS: A total of 9613 adult patients were admitted from the emergency department from 2012 to 2021 that met electronic health record-based Sepsis-3 criteria. Preexisting HF diagnosis was identified by the International Classification of Diseases codes. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 1449 admissions from patients with HF. The relationship between fluid volume and death or discharge to hospice was nonlinear in patients without HF, and approximately linear in patients with HF. Receiving 0-15 mL/kg in the first 6 hours was associated with lower likelihood of death or discharge to hospice compared with 30-45 mL/kg (odds ratio = 0.61; 95% CI, 0.41-0.90; p = 0.01) in HF patients, but no significant difference for non-HF patients. A similar pattern was identified in ICU admissions and some secondary outcomes. Volumes larger than 15-30 mL/kg for non-HF patients and 30-45 mL/kg for ICU-admitted non-HF patients were not associated with improved outcomes. CONCLUSIONS: Early fluid resuscitation showed distinct patterns of potential harm and benefit between patients with and without HF who met Sepsis-3 criteria. Restricted cubic splines analysis highlighted the importance of considering nonlinear fluid outcomes relationships and identified potential points of diminishing returns (15-30 mL/kg across all patients without HF and 30-45 mL/kg when admitted to the ICU). Receiving less than 15 mL/kg was associated with better outcomes in HF patients, suggesting small volumes may be appropriate in select patients. Future studies may benefit from investigating nonlinear fluid-outcome associations and a focus on other conditions like HF.


Subject(s)
Fluid Therapy , Heart Failure , Sepsis , Humans , Retrospective Studies , Male , Female , Heart Failure/therapy , Heart Failure/mortality , Aged , Middle Aged , Fluid Therapy/methods , Sepsis/mortality , Sepsis/therapy , Cohort Studies , Hospital Mortality , Intensive Care Units , Length of Stay
9.
Br J Hosp Med (Lond) ; 85(4): 1-10, 2024 Apr 30.
Article in English | MEDLINE | ID: mdl-38708982

ABSTRACT

There is a significant burden of cardiovascular disease morbidity and mortality in the end-stage kidney disease population, driven by traditional and non-traditional risk factors. Despite its prevalence, heart failure is difficult to diagnose in the dialysis population due to overlapping clinical presentations, limitations of investigations, and the impact on the cardiorenal axis. 'Foundation therapies' are the key medications which improve patient outcomes in heart failure with reduced ejection fraction and include beta-blockers, renin-angiotensin-aldosterone system inhibitors and sodium-glucose cotransporter-2 inhibitors. They are underutilised in the dialysis population due to the exclusion of chronic kidney disease patients from major trials and legitimate clinical concerns e.g. hyperkalaemia, intradialytic hypotension and residual kidney function preservation. A coordinated cardiorenal multidisciplinary approach can guide appropriate diagnostic considerations (biomarkers interpretation, imaging, addressing unique complications of kidney disease), optimise dialysis management (prescription length, frequency and ultrafiltration targets) and when at euvolaemia facilitate the stepwise introduction of appropriate foundation therapies.


Subject(s)
Heart Failure , Kidney Failure, Chronic , Renal Dialysis , Sodium-Glucose Transporter 2 Inhibitors , Humans , Heart Failure/therapy , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/complications , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Adrenergic beta-Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Renin-Angiotensin System/drug effects
10.
Clin Transplant ; 38(5): e15330, 2024 May.
Article in English | MEDLINE | ID: mdl-38716787

ABSTRACT

INTRODUCTION: Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. METHODS: We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. RESULTS: A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n = 25), 2 (28.6%) in the microaxial percutaneous LVAD group (n = 7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n = 9)-p = .039. Sensitized patients were younger (44.7 ± 11.6 years vs. 54.3 ± 12.5 years, p = .044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p = .028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p = .02) and platelets (6 (66.6%) vs. 5 (15.6%), p = .002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p = .57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p = .028. CONCLUSIONS: Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Isoantibodies , Humans , Male , Female , Middle Aged , Isoantibodies/immunology , Isoantibodies/blood , Follow-Up Studies , Adult , Risk Factors , Prognosis , Retrospective Studies , Heart Failure/surgery , Heart Failure/therapy , Graft Rejection/etiology
12.
J Med Case Rep ; 18(1): 238, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38705996

ABSTRACT

BACKGROUND: Takotsubo cardiomyopathy is a novel form of rapidly reversible heart failure occurring secondary to a stressor that mimics an acute coronary event. The underlying etiology of the stressor is highly variable and can include medical procedures. Pacemaker insertion is an infrequent cause of Takotsubo cardiomyopathy. CASE PRESENTATION: An 86-year-old Caucasian woman underwent an uncomplicated pacemaker insertion for symptomatic complete heart block in the background of slow atrial fibrillation. A transient episode of polymorphic ventricular tachycardia was noted on day 1 following the procedure; however, her pacemaker was checked and, as she remained stable, she was discharged home. She presented again 5 days later with symptomatic heart failure. Chest X-ray confirmed pulmonary edema. Echocardiography confirmed new onset severe left ventricle dysfunction. Pacemaker checks were normal and lead placement was confirmed. Though her troponin I was elevated, her coronary angiogram was normal. Contrast enhanced echocardiography suggested apical ballooning favoring Takotsubo cardiomyopathy. She was treated for heart failure and made a good recovery. Her follow-up echocardiography a month later showed significant improvement in left ventricle function. CONCLUSIONS: Takotsubo cardiomyopathy is mediated by a neuro-cardiogenic mechanism due to hypothalamic-pituitary-adrenal axis activation. It generally has a good prognosis. Complications though uncommon, can occur and include arrhythmias. Pacemaker insertion as a precipitant stressor is an infrequent cause of Takotsubo cardiomyopathy. As pacemaker insertions are more frequent in the elderly age group, this phenomenon should be recognized as a potential complication.


Subject(s)
Pacemaker, Artificial , Tachycardia, Ventricular , Takotsubo Cardiomyopathy , Humans , Takotsubo Cardiomyopathy/therapy , Takotsubo Cardiomyopathy/complications , Takotsubo Cardiomyopathy/etiology , Female , Aged, 80 and over , Tachycardia, Ventricular/therapy , Tachycardia, Ventricular/etiology , Echocardiography , Electrocardiography , Heart Failure/therapy , Heart Failure/complications
13.
J Med Internet Res ; 26: e54363, 2024 May 02.
Article in English | MEDLINE | ID: mdl-38696251

ABSTRACT

BACKGROUND: Clinical notes contain contextualized information beyond structured data related to patients' past and current health status. OBJECTIVE: This study aimed to design a multimodal deep learning approach to improve the evaluation precision of hospital outcomes for heart failure (HF) using admission clinical notes and easily collected tabular data. METHODS: Data for the development and validation of the multimodal model were retrospectively derived from 3 open-access US databases, including the Medical Information Mart for Intensive Care III v1.4 (MIMIC-III) and MIMIC-IV v1.0, collected from a teaching hospital from 2001 to 2019, and the eICU Collaborative Research Database v1.2, collected from 208 hospitals from 2014 to 2015. The study cohorts consisted of all patients with critical HF. The clinical notes, including chief complaint, history of present illness, physical examination, medical history, and admission medication, as well as clinical variables recorded in electronic health records, were analyzed. We developed a deep learning mortality prediction model for in-hospital patients, which underwent complete internal, prospective, and external evaluation. The Integrated Gradients and SHapley Additive exPlanations (SHAP) methods were used to analyze the importance of risk factors. RESULTS: The study included 9989 (16.4%) patients in the development set, 2497 (14.1%) patients in the internal validation set, 1896 (18.3%) in the prospective validation set, and 7432 (15%) patients in the external validation set. The area under the receiver operating characteristic curve of the models was 0.838 (95% CI 0.827-0.851), 0.849 (95% CI 0.841-0.856), and 0.767 (95% CI 0.762-0.772), for the internal, prospective, and external validation sets, respectively. The area under the receiver operating characteristic curve of the multimodal model outperformed that of the unimodal models in all test sets, and tabular data contributed to higher discrimination. The medical history and physical examination were more useful than other factors in early assessments. CONCLUSIONS: The multimodal deep learning model for combining admission notes and clinical tabular data showed promising efficacy as a potentially novel method in evaluating the risk of mortality in patients with HF, providing more accurate and timely decision support.


Subject(s)
Deep Learning , Heart Failure , Humans , Heart Failure/mortality , Heart Failure/therapy , Male , Female , Prognosis , Aged , Retrospective Studies , Middle Aged , Electronic Health Records , Hospitalization/statistics & numerical data , Hospital Mortality , Aged, 80 and over
14.
Sensors (Basel) ; 24(9)2024 May 03.
Article in English | MEDLINE | ID: mdl-38733027

ABSTRACT

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.


Subject(s)
Heart Failure , Humans , Heart Failure/therapy , Heart Failure/physiopathology , Cardiology/methods , Monitoring, Physiologic/methods , Monitoring, Physiologic/instrumentation , Disease Management , Hemodynamics/physiology
15.
Isr Med Assoc J ; 26(5): 278-282, 2024 May.
Article in English | MEDLINE | ID: mdl-38736341

ABSTRACT

BACKGROUND: Long-term support with a HeartMate 3 (HM3) left ventricular assist device (LVAD) has improved outcomes of patients with end-stage heart failure. However, there is a paucity of data on the outcomes of patients who underwent concomitant cardiac surgical procedure (CCSP) during HM3-LVAD implantation. OBJECTIVES: To assess our single-center experience with patients who underwent CCSP during the implantation of an HM3-LVAD. METHODS: From December 2016 until April 2022, 131 adult patients underwent HM3-LVAD implantation. A total of 23 patients underwent CCSP during the HM3-LVAD implantation+CCSP, and 108 underwent only HM3-LVAD implantation (HM3-only). RESULTS: The median age was 59 ± 11 years (range 54-67), 82% (n=108) were male, and 76% (n=100) were implanted as a bridge-to-transplant. The concomitant procedures performed during the implantation included 8 aortic valve repairs/replacements, 14 tricuspid valve repairs, 4 patent foramen ovales or atrial septal defect closures, and 3 other cardiac procedures. The mean cardiopulmonary bypass time was 113 ± 58 minutes for the HM3-only group and 155 ± 47 minutes for the HM3+CCSP group (P = 0.007). The mortality rates at 30 days, 6 months, and 12 months post-implantation were 2 (9%), 5 (22%), and 6 (26%) respectively for the HM3+CCSP group, and 7 (6%), 18 (17%), and 30 (28%) for the HM3-only group (P = 0.658, 0.554, and 1.000). CONCLUSIONS: Our experience demonstrated no significant difference in the 30-day, 6-month, and 12-month mortality rates for patients who underwent a CCSP during HM3-LVAD implantation compared to patients who did not undergo CCSP during HM3-LVAD implantation.


Subject(s)
Cardiac Surgical Procedures , Heart Failure , Heart-Assist Devices , Humans , Heart-Assist Devices/statistics & numerical data , Male , Female , Middle Aged , Heart Failure/surgery , Heart Failure/mortality , Heart Failure/therapy , Aged , Cardiac Surgical Procedures/methods , Retrospective Studies , Treatment Outcome , Prosthesis Implantation/methods
16.
J Heart Lung Transplant ; 43(6): 889-900, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38713124

ABSTRACT

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).


Subject(s)
Feasibility Studies , Heart Failure , Heart-Assist Devices , Humans , Child, Preschool , Child , Male , Infant , Female , Prospective Studies , Heart Failure/therapy , Heart Failure/surgery , Heart Failure/physiopathology , Miniaturization , Prosthesis Design , Treatment Outcome , United States
17.
Heart Lung ; 66: 56-70, 2024.
Article in English | MEDLINE | ID: mdl-38583277

ABSTRACT

BACKGROUND: Social determinants of health (SDOH) may influence the clinical management of patients with heart failure. Further research is warranted on the relationship between SDOH and Ventricular Assist Device (VAD) therapy for heart failure. OBJECTIVES: The purpose of this integrative review was to synthesize the state of knowledge on the intersection of SDOH with VAD therapy. METHODS: Guided by Whittemore and Knafl's methodology, this literature search captured three concepts of interest including VAD therapy, SDOH, and their domains of intersection with patient selection, decision-making, treatment outcome, and resource allocation. CINAHL, Embase, PsycINFO, PubMed, and Web of Science were searched in March 2023. Articles were included if they were peer-reviewed publications in English, published between 2006 and 2023, conducted in the United States, and examined VAD therapy in the context of adult patients (age ≥ 18 years). RESULTS: 22 quantitative studies meeting the inclusion criteria informed the conceptualization of SDOH using the Healthy People 2030 framework. Four themes captured how the identified SDOH intersected with different processes relating to VAD therapy: patient decision-making, healthcare access and resource allocation, patient selection, and treatment outcomes. Most studies addressed the intersection of SDOH with healthcare access and treatment outcomes. CONCLUSION: This review highlights substantial gaps in understanding how SDOH intersect with patient and patient selection for VAD. More research using mixed methods designs is warranted. On an institutional level, addressing bias and discrimination may have mitigated health disparities with treatment outcomes, but further research is needed for implementing system-wide change. Standardized assessment of SDOH is recommended throughout clinical practice from patient selection to outpatient VAD care.


Subject(s)
Heart Failure , Heart-Assist Devices , Social Determinants of Health , Humans , Heart-Assist Devices/statistics & numerical data , Heart Failure/therapy , Patient Selection
18.
Curr Heart Fail Rep ; 21(3): 186-193, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38662154

ABSTRACT

PURPOSE OF REVIEW: Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10 years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. RECENT FINDINGS: In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10 years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.


Subject(s)
Cost-Benefit Analysis , Defibrillators, Implantable , Heart Failure , Humans , Heart Failure/therapy , Heart Failure/economics , Defibrillators, Implantable/economics , Cardiac Resynchronization Therapy/economics , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy Devices/economics , Quality of Life , Quality-Adjusted Life Years , Pacemaker, Artificial/economics
19.
Circ J ; 88(5): 692-702, 2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38569914

ABSTRACT

BACKGROUND: This study investigated whether the chronic use of adaptive servo-ventilation (ASV) reduces all-cause mortality and the rate of urgent rehospitalization in patients with heart failure (HF).Methods and Results: This multicenter prospective observational study enrolled patients hospitalized for HF in Japan between 2019 and 2020 who were treated either with or without ASV therapy. Of 845 patients, 110 (13%) received chronic ASV at hospital discharge. The primary outcome was a composite of all-cause death and urgent rehospitalization for HF, and was observed in 272 patients over a 1-year follow-up. Following 1:3 sequential propensity score matching, 384 patients were included in the subsequent analysis. The median time to the primary outcome was significantly shorter in the ASV than in non-ASV group (19.7 vs. 34.4 weeks; P=0.013). In contrast, there was no significant difference in the all-cause mortality event-free rate between the 2 groups. CONCLUSIONS: Chronic use of ASV did not impact all-cause mortality in patients experiencing recurrent admissions for HF.


Subject(s)
Heart Failure , Patient Readmission , Humans , Heart Failure/mortality , Heart Failure/therapy , Aged , Male , Female , Prospective Studies , Patient Readmission/statistics & numerical data , Aged, 80 and over , Japan/epidemiology , Middle Aged , Time Factors , Treatment Outcome
20.
JAMA ; 331(17): 1499-1501, 2024 05 07.
Article in English | MEDLINE | ID: mdl-38598231

ABSTRACT

This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices.


Subject(s)
Heart-Assist Devices , Heart-Assist Devices/economics , Humans , United States , Cardiologists , Heart Failure/therapy
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