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Heart failure (HF) is a leading cause of hospitalization in older adults. Patients are at high risk of readmission and death following hospitalization for HF. There is no standard approach of health care delivery during the hospital-to-home transition period, leaving missed opportunities in care optimization. In this review, we discuss contemporary randomized clinical trials that tested decongestion strategies, disease-modifying therapies, and health care services that inform the care of patients with worsening HF. We provide evidence-informed recommendations for optimizing therapies and improving outcomes during and following hospitalization for HF. These include adequate decongestion with loop diuretics and select sequential nephron blockade strategies based on early evaluation of diuretic response; initiation of disease-modifying pharmacotherapies prior to hospital discharge with close follow-up and optimization after discharge; cardiac rehabilitation; and transitional or palliative care referral post-hospitalization. Evidence-based implementation strategies to facilitate broad uptake include digital health tools and algorithm-driven optimization of pharmacotherapies.
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AIMS: Compared with those without obesity, patients with obesity-related heart failure with preserved ejection fraction (HFpEF) have worse symptoms, haemodynamics, and outcomes. Current weight loss strategies (diet, drug, and surgical) work through decreased energy intake rather than increased expenditure and cause significant loss of skeletal muscle mass in addition to adipose tissue. This may have adverse implications for patients with HFpEF, who already have reduced skeletal muscle mass and function and high rates of physical frailty. Mitochondrial uncoupling agents may have unique beneficial effects by producing weight loss via increased catabolism rather than reduced caloric intake, thereby causing loss of adipose tissue while sparing skeletal muscle. HU6 is a controlled metabolic accelerator that is metabolized to the mitochondrial uncoupling agent 2,4-dinotrophenol. HU6 selectively increases carbon oxidation from fat and glucose while also decreasing toxic reactive oxygen species (ROS) production. In addition to sparing skeletal muscle loss, HU6 may have other benefits relevant to obesity-related HFpEF, including reduced specific tissue depots contributing to HFpEF; improved glucose utilization; and reduction in systemic inflammation via both decreased ROS production from mitochondria and decreased cytokine elaboration from excess, dysfunctional adipose. METHODS: We describe the rationale and design of HuMAIN-HFpEF, a Phase 2a randomized, double-blind, placebo-controlled, dose-titration, parallel-group trial in patients with obesity-related HFpEF to evaluate the effects of HU6 on weight loss, body composition, exercise capacity, cardiac structure and function, metabolism, and inflammation, and identify optimal dosage for future Phase 3 trials. CONCLUSIONS: HuMAIN will test a promising novel agent for obesity-related HFpEF.
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BACKGROUND: Quantifying guideline-directed medical therapy (GDMT) intensity is foundational for improving heart failure (HF) care. Existing measures discount dose intensity or use inconsistent weighting. METHODS: The Kansas City Medical Optimization (KCMO) score is the average of total daily to target dose percentages for eligible GDMT, reflecting the percentage of optimal GDMT prescribed (range, 0-100). In Change the Management of Patients With HF, we computed KCMO, HF collaboratory (0-7), and modified HF Collaboratory (0-100) scores for each patient at baseline and for 1-year change in established GDMT at the time (mineralocorticoid receptor antagonist, ß-blocker, ACE [angiotensin-converting enzyme] inhibitor/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor). We compared baseline and 1-year change distributions and the coefficient of variation (SD/mean) across scores. RESULTS: Among 4532 patients at baseline, mean KCMO, HF collaboratory, and modified HF Collaboratory scores were 38.8 (SD, 25.7), 3.4 (1.7), and 42.2 (22.2), respectively. The mean 1-year change (n=4061) for KCMO was -1.94 (17.8); HF collaborator, -0.11 (1.32); and modified HF Collaboratory, -1.35 (19.8). KCMO had the highest coefficient of variation (0.66), indicating greater variability around the mean than the HF collaboratory (0.49) and modified HF Collaboratory (0.53) scores, reflecting higher resolution of the variability in GDMT intensity across patients. CONCLUSIONS: KCMO measures GDMT intensity by incorporating dosing and treatment eligibility, provides more granularity than existing methods, is easily interpretable (percentage of ideal GDMT), and can be adapted as performance measures evolve. Further study of its association with outcomes and its usefulness for quality assessment and improvement is needed.
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Inhibidores de la Enzima Convertidora de Angiotensina , Insuficiencia Cardíaca , Guías de Práctica Clínica como Asunto , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Guías de Práctica Clínica como Asunto/normas , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Femenino , Masculino , Antagonistas Adrenérgicos beta/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Adhesión a Directriz/normas , Anciano , Antagonistas de Receptores de Angiotensina/uso terapéutico , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Although sodium glucose co-transporter 2 inhibitors (SGLT2is) improve heart failure (HF)-related symptoms and outcomes in HF with preserved ejection fraction (HFpEF), underlying mechanisms remain unclear. In HF with reduced EF, dapagliflozin altered ketone and fatty acid metabolites vs placebo; however, metabolite signatures of SGLT2is have not been well elucidated in HFpEF. OBJECTIVES: The goal of this study was to assess whether SGLT2i treatment altered systemic metabolic pathways and their relationship to outcomes in HFpEF. METHODS: Targeted profiling of 64 metabolites was performed from 293 participants in PRESERVED-HF (Dapagliflozin in PRESERVED Ejection Fraction Heart Failure), a 12-week, placebo-controlled trial of dapagliflozin. Linear regression assessed changes in metabolite factors defined by principal components analysis (PCA) with dapagliflozin vs placebo. The relationship between changes in metabolite factors with changes in study endpoints was also assessed. RESULTS: The mean age was 70 ± 11 years, 58% were female, and 29% were Black. There were no significant differences in 12 PCA-derived metabolite factors between treatment arms, including metabolites reflecting ketone, fatty acid, or branched-chain amino acid (BCAA) pathways. Combining treatment arms, changes in BCAAs and branched-chain ketoacids were negatively associated with changes in N-terminal pro-B-type natriuretic peptide; changes in medium-/long-chain acylcarnitines were positively associated with changes in N-terminal pro-B-type natriuretic peptide and negatively associated with changes in 6-minute walk test distance; and changes in ketones were negatively associated with changes in weight, without treatment interaction. CONCLUSIONS: Leveraging targeted metabolomics in a placebo-controlled SGLT2i trial of HFpEF, dapagliflozin did not alter systemic metabolic as reflected by circulating metabolites, in contrast with reported effects in HF with reduced ejection fraction. Metabolite biomarkers reflecting BCAA, ketone, and fatty acid metabolism were associated with markers of disease severity, suggesting a role for potential novel treatment targets. (Dapagliflozin in PRESERVED Ejection Fraction Heart Failure [PRESERVED-HF]; NCT03030235).
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Compuestos de Bencidrilo , Glucósidos , Insuficiencia Cardíaca , Metabolómica , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Volumen Sistólico , Humanos , Compuestos de Bencidrilo/uso terapéutico , Glucósidos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/metabolismo , Femenino , Volumen Sistólico/fisiología , Anciano , Masculino , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Persona de Mediana Edad , Ácidos Grasos/metabolismo , Péptido Natriurético Encefálico/metabolismo , Péptido Natriurético Encefálico/sangre , Biomarcadores/metabolismo , Biomarcadores/sangre , Fragmentos de Péptidos/sangre , Fragmentos de Péptidos/metabolismoAsunto(s)
Enfermedad Crítica , Miositis , Humanos , Miositis/epidemiología , Miositis/inmunología , Miositis/sangre , Enfermedad Crítica/epidemiología , Masculino , Femenino , Persona de Mediana Edad , Prevalencia , Anciano , Autoanticuerpos/sangre , Autoanticuerpos/inmunología , COVID-19/inmunología , COVID-19/epidemiología , COVID-19/complicacionesRESUMEN
BACKGROUND: There are limited data on substance use (SU) and cardiovascular disease (CVD)-related mortality trends in the United States. We aimed to evaluate SU+CVD-related deaths in the United States using the Centers for Disease Control and Prevention Wide-Ranging, Online Data for Epidemiologic Research database. METHODS AND RESULTS: The Multiple Cause-of-Death Public Use record death certificates were used to identify deaths related to both SU and CVD. Crude, age-adjusted mortality rates, annual percent change, and average annual percent changes with a 95% CI were analyzed. Between 1999 and 2019, there were 636 572 SU+CVD-related deaths (75.6% men, 70.6% non-Hispanic White individuals, 65% related to alcohol). Age-adjusted mortality rates per 100 000 population were pronounced in men (22.5 [95% CI, 22.6-22.6]), American Indian or Alaska Native individuals (37.7 [95% CI, 37.0-38.4]), nonmetropolitan/rural areas (15.2 [95% CI, 15.1-15.3]), and alcohol-related death (9.09 [95% CI, 9.07 to 9.12]). The overall SU+CVD-related age-adjusted mortality rates increased from 9.9 (95% CI, 9.8-10.1) in 1999 to 21.4 (95% CI, 21.2-21.6) in 2019 with an average annual percent change of 4.0 (95% CI, 3.7-4.3). Increases in SU+CVD-related average annual percent change were noted across all subgroups and were pronounced among women (4.8% [95% CI, 4.5-5.1]), American Indian or Alaska Native individuals, younger individuals, nonmetropolitan areas, and cannabis and psychostimulant users. CONCLUSIONS: There was a prominent increase in SU+CVD-related mortality in the United States between 1999 and 2019. Women, non-Hispanic American Indian or Alaska Native individuals, younger individuals, nonmetropolitan area residents, and users of cannabis and psychostimulants had pronounced increases in SU+CVD mortality.
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Enfermedades Cardiovasculares , Trastornos Relacionados con Sustancias , Femenino , Humanos , Masculino , Indio Americano o Nativo de Alaska , Enfermedades Cardiovasculares/mortalidad , Trastornos Relacionados con Sustancias/mortalidad , Estados Unidos/epidemiología , BlancoRESUMEN
BACKGROUND: Nonintravenous inotropic-delivery options are needed for patients with inotropic-dependent heart failure (HF) to reduce the costs, infections and thrombotic risks associated with chronic central venous catheters and home infusion services. METHODS: We developed a novel, concentrated formulation of nebulized milrinone for inhalation and evaluated the feasibility, safety and pharmacokinetic profile in a prospective, single-arm, phase I clinical trial. We enrolled 10 patients with stage D HF requiring inotropic therapy during a hospital admission for acute HF. Milrinone 60 mg/4 mL was inhaled via nebulization 3 times daily for 48 hours. The coprimary outcomes were adverse events and pharmacokinetic profiles of inhaled milrinone. Acute changes in hemodynamic parameters were secondary outcomes. RESULTS: A concentrated nebulized milrinone formulation was well tolerated, without hypotensive events, arrhythmias or inhalation-related adverse events requiring discontinuation. Nebulized milrinone produced serum concentrations in the goal therapeutic range with a median plasma milrinone trough concentration of 39 (17-66) ng/mL and a median peak concentration of 207 (134-293) ng/mL. There were no serious adverse events. From baseline to 24 hours, mean pulmonary artery saturation increased (60% ± 7%-65 ± 5%; Pâ¯=â¯0.001), and mean cardiac index increased (2.0 ± 0.5 mL/min/1.73m2-2.5 ± 0.1 mL/min/1.73m2; Pâ¯=â¯0.001) with nebulized milrinone. CONCLUSIONS: In a proof-of-concept study, a concentrated, nebulized milrinone formulation for inhalation was safe and produced therapeutic serum milrinone concentrations. Nebulized milrinone was associated with improved hemodynamic parameters of cardiac output in a population with advanced HF. These promising results require further investigation in a longer-term trial in patients with inotrope-dependent advanced HF.
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Insuficiencia Cardíaca , Milrinona , Humanos , Milrinona/farmacología , Milrinona/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Estudios Prospectivos , Hemodinámica , Gasto Cardíaco , Cardiotónicos/uso terapéuticoRESUMEN
BACKGROUND: Inhibition of the mammalian target of rapamycin (mTor) pathway after heart transplantation has been associated with reduced progression of coronary allograft vasculopathy (CAV). The application of low-dose mTOR inhibition in the setting of modern immunosuppression, including tacrolimus, remains an area of limited exploration. METHODS: This retrospective study included patients who received heart transplantation between January 2009 and January 2019 and had baseline, 1-year and 2-3-year coronary angiography with intravascular ultrasound (IVUS). Intimal thickness in 5 segments along the left anterior descending artery was compared across imaging time points in patients who were transitioned to low-dose mTOR inhibitor (sirolimus) vs standard treatment with mycophenolate on a background of tacrolimus. Long-term adverse cardiovascular outcomes (revascularization, severe CAV, retransplant, and cardiovascular death) were also assessed. RESULTS: Among 216 patients (mean age 51.5 ± 11.9 years, 77.8% men, 80.1% white), 81 individuals (37.5%) were switched to mTOR inhibition. mTOR inhibition was associated with a reduction in intimal thickness by 0.05 mm (95% CI 0.02-0.07; P < 0.001). This reduction was driven by patients who met the criteria for rapidly progressive CAV 1-year post-transplant (0.12 mm; Pâ¯=â¯0.016 for interaction). After a median follow-up of 8.6 (IQR 6.6-11) years, 40 patients had major adverse cardiovascular outcomes. The use of mTOR inhibitors was not significantly associated with cardiovascular outcomes (Pâ¯=â¯0.669). CONCLUSION: Transitioning patients after heart transplantation to an immunosuppression regimen composed of low-dose mTOR inhibition and tacrolimus was associated with a lack of progression of CAV, particularly in those with rapidly progressive CAV at 1 year, but not with long-term cardiovascular outcomes.
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Enfermedad de la Arteria Coronaria , Insuficiencia Cardíaca , Trasplante de Corazón , Masculino , Humanos , Adulto , Persona de Mediana Edad , Femenino , Tacrolimus/uso terapéutico , Estudios Retrospectivos , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/cirugía , Estudios de Seguimiento , Ultrasonografía Intervencional , Insuficiencia Cardíaca/tratamiento farmacológico , Sirolimus/uso terapéutico , Trasplante de Corazón/efectos adversos , Angiografía Coronaria , Aloinjertos , Serina-Treonina Quinasas TOR/uso terapéuticoRESUMEN
Background: Hemodynamic Frontiers in Heart Failure (HF2) is a multicenter academic research consortium comprised of 14 US institutions with mature remote monitoring programs for ambulatory patients with heart failure (HF). The consortium developed a retrospective and prospective registry of patients implanted with a wireless pulmonary artery pressure (PAP) sensor. Goals/aims: HF2 registry collects demographic, clinical, laboratory, echocardiographic (ECHO), and hemodynamic data from patients with PAP sensors. The aims of HF2 are to advance understanding of HF and to accelerate development of novel diagnostic and therapeutic innovations. Methods: HF2 includes adult patients implanted with a PAP sensor as per FDA indications (New York Heart Association (NYHA) Class III HF functional class with a prior hospitalization, or patients with NYHA Class II or brain natriuretic peptide (BNP) elevation without hospitalization) at a HF2 member site between 1/1/19 to present. HF2 registry is maintained at University of Kansas Medical Center (KUMC). The registry was approved by the institutional review board (IRB) at all participating institutions with required data use agreements. Institutions report data into the electronic registry database using REDCap, housed at KUMC. Results: This initial data set includes 254 patients implanted from the start of 2019 until May 2023. At time of device implant, the cohort average age is 73 years old, 59.8% are male, 72% have NYHA Class III HF, 40% have left ventricular ejection fraction (LVEF) < 40%, 35% have LVEF > 50%, mean BNP is 560â pg/ml, mean N-Terminal pro-BNP (NTproBNP) is 5,490â pg/ml, mean creatinine is 1.65â mg/dl. Average baseline hemodynamics at device implant are right atrial pressure (RAP) of 11â mmHg, pulmonary artery systolic pressure (PASP) of 47â mmHg, pulmonary artery diastolic pressure (PADP) 21â mmHg, mean pulmonary artery pressure (mPAP) of 20â mmHg, pulmonary capillary wedge pressure (PCWP) of 19â mmHg, cardiac output (CO) of 5.3â L/min, and cardiac index (CI) of 2.5â L/min/m2. Conclusion: A real-world registry of patients implanted with a PAP sensor enables long-term evaluation of hemodynamic and clinic outcomes in highly-phenotyped ambulatory HF patients, and creates a unique opportunity to validate and test novel diagnostic and therapeutic approaches to HF.
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BACKGROUND: Heart failure with preserved ejection fraction is associated with significant functional limitations, yet treatments for improving exercise performance have been elusive. We sought to explore the association between prespecified patient characteristics and changes in 6-minute walk distance that constitute a clinically significant response to dapagliflozin. METHODS: We performed a responder analysis to understand patient characteristics associated with clinically meaningful improvement in 6-minute walk test (6MWT) distance ≥15 m among patients randomized to 12 weeks of dapagliflozin versus placebo in the double-blind PRESERVED-HF trial (Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Preserved Ejection Fraction Heart Failure). RESULTS: A total of 289 randomized patients had 6MWT distance completed at baseline and 12 weeks. Patients randomized to dapagliflozin improved walking distance by ≥15 m more frequently than those on placebo (n=64, 44% versus n=48, 34%). After adjusting for baseline covariates, patients randomized to dapagliflozin were more likely to experience a clinically meaningful improvement in 6MWT distance compared with those that received placebo (adjusted odds ratio, 1.66 [95% CI, 1.00-2.75]; P=0.05). Dapagliflozin-treated patients were also less likely to have a ≥15 m reduction in 6MWT distance compared with placebo-treated patients (adjusted odds ratio, 0.56 [95% CI, 0.33-0.94]; P=0.03). These results were consistent across all prespecified subgroups (all P values for interaction were not significant). CONCLUSIONS: Compared with those on placebo, patients with heart failure with preserved ejection fraction randomized to dapagliflozin were more likely to experience a clinically meaningful improvement and less likely to experience a deterioration in physical function over 12 weeks as measured by 6MWT distance. Beneficial response to dapagliflozin was consistent across prespecified subgroups. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03030235.
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Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/tratamiento farmacológico , Volumen Sistólico/fisiología , Compuestos de Bencidrilo/efectos adversos , Caminata , Función Ventricular IzquierdaRESUMEN
AIM: To study effect of change in position (supine and standing) on pulmonary artery pressure (PAP) in ambulatory heart failure (HF) patients. METHODS: Seventeen patients with CardioMEMS® sensor and stable heart failure were consented and included in this single center study. Supine and standing measurements were obtained with at least 5 min interval between the two positions. These measurements included PAP readings utilizing the manufacturer handheld interrogator obtaining 10 s data in addition to the systemic blood pressure and heart rate recordings. RESULTS: Mean supine and standing readings and their difference (Δ) were as follows respectively: Systolic PAP were 33.4 (± 11.19), 23.6 (± 10) and Δ was 9.9 mmHg (p = 0.0001), diastolic PAP were 14.2 (± 5.6), 7.9 (± 5.7) and Δ was 6.3 mmHg (p = 0.0001) and mean PAP were 21.8 (± 7.8), 14 (± 7.2) and Δ was 7.4 mmHg (p = 0.0001) while the systemic blood pressure did not vary significantly. CONCLUSION: There is orthostatic variation of PAP in ambulatory HF patients demonstrating a mean decline with standing in diastolic PAP by 6.3 mmHg, systolic PAP by 9.9 mmHg and mean PAP by 7.4 mmHg in absence of significant orthostatic variation in systemic blood pressure or heart rate. These findings have significant clinical implications and inform that PAP in each patient should always be measured in the same position. Since initial readings at the time of implant were taken in supine position, it may be best to use supine position or to obtain a baseline standing PAP reading if standing PAP is planned on being used.
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Presión Sanguínea , Insuficiencia Cardíaca , Hipotensión Ortostática , Arteria Pulmonar , Humanos , Presión Sanguínea/fisiología , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/fisiopatología , Frecuencia Cardíaca/fisiología , Arteria Pulmonar/fisiopatología , Hipotensión Ortostática/complicaciones , Hipotensión Ortostática/fisiopatología , Posición de Pie , Posición Supina/fisiologíaRESUMEN
AIMS: The HeartLogic multisensor index has been found to be a sensitive predictor of worsening heart failure (HF). However, there is limited data on this index's association and its constituent sensors with HF readmissions. METHODS AND RESULTS: The PREEMPT-HF study is a global, multicentre, prospective, observational, single-arm, post-market study. HF patients with an implantable defibrillator device or cardiac resynchronization therapy with defibrillator with HeartLogic capabilities were eligible if sensor data collection was turned on and the HeartLogic feature was not enabled. Thus, the HeartLogic Index/alert and heart sounds sensor trends were unavailable via the LATITUDE remote monitoring system to clinicians (blinded). Evaluation of subject medical records at 6 months and a final in-clinic visit at 12 months was required for collection of all-cause hospitalizations and HF outpatient visits. The purpose of this study is exploratory, no formal hypothesis tests are planned, and no adjustment for multiple testing will be performed. A total of 2183 patients were enrolled at 103 sites between June 2018 and June 2020. A significant proportion of the patients were implanted with implantable defibrillator devices (39%) versus cardiac resynchronization therapy with defibrillator (61%); were female (27%); over 65 (61%); New York Heart Association class I (13%), II (53%), and III (33%); ejection fraction < 25% (21%); ischaemic (50%); and with a history of renal dysfunction (23%). CONCLUSIONS: The PREEMPT study will provide clinical data and blinded sensor trends for the characterization of sensor changes with HF readmission, tachyarrhythmias, and event subgroups. These data may help to refine the clinical use of HeartLogic and to improve patient outcomes.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca , Femenino , Humanos , Masculino , Terapia de Resincronización Cardíaca/métodos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Hospitalización , Estudios ProspectivosRESUMEN
Successful remote patient monitoring depends on bidirectional interaction between patients and multidisciplinary clinical teams. Invasive pulmonary artery pressure monitoring has been shown to reduce heart failure (HF) hospitalizations, facilitate guideline-directed medical therapy optimization, and improve quality of life. Cardiac implantable electronic device-based multiparameter monitoring has shown encouraging results in predicting future HF-related events. Potential expanded indications for remote monitoring include guideline-directed medical therapy optimization, application to specific populations, and subclinical detection of HF. Voice analysis, inferior vena cava diameter monitoring, and artificial intelligence-based remote electrocardiogram show potential to gain some merit in remote patient monitoring in HF.
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Insuficiencia Cardíaca , Calidad de Vida , Humanos , Inteligencia Artificial , Hospitalización , Monitoreo Fisiológico/métodos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapiaRESUMEN
Mobile health (mHealth) is an emerging approach to health care. It involves wearable, connected technologies that facilitate patient-symptom or physiological monitoring, support clinical feedback to patients and physicians, and promote patients' education and self-care. Evolving algorithms may involve artificial intelligence and can assist in data aggregation and health care teams' interpretations. Ultimately, the goal is not merely to collect data; rather, it is to increase actionability. mHealth technology holds particular promise for patients with heart failure, especially those with frequently changing clinical status. mHealth, ideally, can identify care opportunities, anticipate clinical courses and augment providers' capacity to implement, titrate and monitor interventions safely, including evidence-based therapies. Although there have been marked advancements in the past decade, uncertainties remain for mHealth, including questions regarding optimal indications and acceptable payment models. In regard to mHealth capability, a better understanding is needed of the incremental benefit of mHealth data over usual care, the accuracy of specific mHealth data points in making clinical care decisions, and the efficiency and precision of algorithms used to dictate actions. Importantly, emerging regulations in the wake of COVID-19, and now the end of the federal public health emergency, offer both opportunity and risks to the broader adoption of mHealth-enabled services. In this review, we explore the current state of mHealth in heart failure, with particular attention to the opportunities and challenges this technology creates for patients, health care providers and other stakeholders.
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COVID-19 , Insuficiencia Cardíaca , Telemedicina , Humanos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Inteligencia Artificial , COVID-19/epidemiología , Atención a la SaludRESUMEN
BACKGROUND: There is a need for simple, noninvasive solutions to remotely monitor and predict worsening heart failure (HF) events. SCALE-HF 1 (Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events) is a prospective, multicenter study that will develop and assess the accuracy of the heart function index-a composite algorithm of noninvasive hemodynamic biomarkers from a cardiac scale-in predicting worsening HF events. METHODS: Approximately 300 patients with chronic HF and recent decompensation will be enrolled in this observational study for model development. Patients will be encouraged to take daily cardiac scale measurements. RESULTS: Approximately 50 HF events, defined as an urgent, unscheduled clinic, emergency department, or hospitalization for worsening HF will be used for model development. The composite index will be developed from hemodynamic biomarkers derived from ECG, ballistocardiogram, and impedance plethysmogram signals measured from the cardiac scale. Biomarkers of interest include weight, peripheral impedance, pulse rate and variability, and estimates of stroke volume, cardiac output, and blood pressure captured through the cardiac scale. The sensitivity, unexplained alert rate, and alerting time of the index in predicting worsening HF events will be evaluated and compared with the performance of simple weight-based rule-of-thumb algorithms (eg, weight increase of 3 lbs in 1 day or 5 lbs in 7 days) that are often used in practice. CONCLUSIONS: SCALE-HF 1 is the first study to develop and evaluate the performance of a composite index derived from noninvasive hemodynamic biomarkers measured from a cardiac scale in predicting worsening HF events. Subsequent studies will validate the heart function index and assess its ability to improve patient outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04882449.
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Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/diagnóstico , Estudios Prospectivos , HospitalizaciónRESUMEN
BACKGROUND: Heart transplantation is the gold-standard therapy for end-stage heart failure, but rates of donor-heart use remain low due to various factors that are often not evidence based. The impact of donor hemodynamics obtained via right-heart catheterization on recipient survival remains unclear. METHODS: The United Network for Organ Sharing registry was used to identify donors and recipients from September 1999-December 2019. Donor hemodynamics data were obtained and analyzed using univariate and multivariable logistical regression, with the primary endpoints being 1- and 5-year post-transplant survival. RESULTS: Of the 85,333 donors who consented to heart transplantation during the study period, 6573 (7.7%) underwent right-heart catheterization, of whom 5531 eventually underwent procurement and transplantation. Donors were more likely to undergo right-heart catheterization if they had high-risk criteria. Recipients who had donor hemodynamic assessment had 1- and 5-year survival rates similar to those without donor hemodynamic assessment (87% vs 86%, 1 year). Abnormal hemodynamics were common in donor hearts but did not impact recipient survival rates, even when risk-adjusted in multivariable analysis. CONCLUSIONS: Donors with abnormal hemodynamics may represent an opportunity to expand the pool of viable donor hearts.